hbd updates outcomes from decade and current activity · hbd has made a great contribution to solve...
TRANSCRIPT
HBD Updates
Outcomes from Decade and Current Activity
Yuka SUZUKI PhD Director Office of Medical Devices II
Pharmaceuticals and Medical Devices Agency Japan
bull Letrsquos find a way to break through the developmental barrier (harmonize) between the US and Japan by taking a real action not just discussing hypothetically
By Doing
Concept of Harmonization By Doing(HBD)
Medical Devices Regulations
EU
Japan US
Pre-market review
Notified body certification
(requirements depend on device
classification)
Class IV Ministerrsquos approval
Class III Ministerrsquos approval
Class II Notified body certification
Class I Self-declaration
Class III PMA Approval
Class II 510(k) clearance
Class I exemption
Notified body reviewcertification Self declaration Governmental approvallicense
Ris
k
GuidanceSuggestions ReportRequest
Working
Groups
HBD Structure
Steering Committee
MHLW
Industry
Academia
Regulatory
WG1Global Cardiovascular Device Trials WG2 Study on Post-market Registry WG3Clinical Trials Infrastructure and Methodology WG4 Regulatory Convergence and Communication
Significance of Global Clinical Trial PMA
application
IDE
application
PMA
approval approval
application approval
Pre-IDE
meeting consultation
Clinical trial
consultation
consultation
Resolution of
the device lag
Conducted US-Japan joint clinical trials for two drug eluting stents
- ENDEAVOR（Medtronic Japan Co Ltd）
- XIENCE V（Guidant Japan KK（then））
Place of discussion needed on the issues associated with
conducting the joint clinical trial with single protocol
rarr WG1 has inherited duties
Collaborative Consultation and Review of Premarketing
Applications Pilot Program
bull The first drug eluting SFA stent both in the US and Japan
Global Clinical Trial Through HBD Activity
Contribute to the global device development by presenting proposed guidelines
through intensive discussions within SWG composed of experts in each ROI
bull Global clinical trial
bull Single protocol POC project
bull Virtual HBD
bull Discuss areas of interest
Scientific session
bull Discuss and formulate solutions for specific challenges in innovative device areas
bull Present specific recommendations for a single protocol Expert SWG
Scientific
session
SWG
POC
Project
HBD-WG1 Activity
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
bull Letrsquos find a way to break through the developmental barrier (harmonize) between the US and Japan by taking a real action not just discussing hypothetically
By Doing
Concept of Harmonization By Doing(HBD)
Medical Devices Regulations
EU
Japan US
Pre-market review
Notified body certification
(requirements depend on device
classification)
Class IV Ministerrsquos approval
Class III Ministerrsquos approval
Class II Notified body certification
Class I Self-declaration
Class III PMA Approval
Class II 510(k) clearance
Class I exemption
Notified body reviewcertification Self declaration Governmental approvallicense
Ris
k
GuidanceSuggestions ReportRequest
Working
Groups
HBD Structure
Steering Committee
MHLW
Industry
Academia
Regulatory
WG1Global Cardiovascular Device Trials WG2 Study on Post-market Registry WG3Clinical Trials Infrastructure and Methodology WG4 Regulatory Convergence and Communication
Significance of Global Clinical Trial PMA
application
IDE
application
PMA
approval approval
application approval
Pre-IDE
meeting consultation
Clinical trial
consultation
consultation
Resolution of
the device lag
Conducted US-Japan joint clinical trials for two drug eluting stents
- ENDEAVOR（Medtronic Japan Co Ltd）
- XIENCE V（Guidant Japan KK（then））
Place of discussion needed on the issues associated with
conducting the joint clinical trial with single protocol
rarr WG1 has inherited duties
Collaborative Consultation and Review of Premarketing
Applications Pilot Program
bull The first drug eluting SFA stent both in the US and Japan
Global Clinical Trial Through HBD Activity
Contribute to the global device development by presenting proposed guidelines
through intensive discussions within SWG composed of experts in each ROI
bull Global clinical trial
bull Single protocol POC project
bull Virtual HBD
bull Discuss areas of interest
Scientific session
bull Discuss and formulate solutions for specific challenges in innovative device areas
bull Present specific recommendations for a single protocol Expert SWG
Scientific
session
SWG
POC
Project
HBD-WG1 Activity
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Medical Devices Regulations
EU
Japan US
Pre-market review
Notified body certification
(requirements depend on device
classification)
Class IV Ministerrsquos approval
Class III Ministerrsquos approval
Class II Notified body certification
Class I Self-declaration
Class III PMA Approval
Class II 510(k) clearance
Class I exemption
Notified body reviewcertification Self declaration Governmental approvallicense
Ris
k
GuidanceSuggestions ReportRequest
Working
Groups
HBD Structure
Steering Committee
MHLW
Industry
Academia
Regulatory
WG1Global Cardiovascular Device Trials WG2 Study on Post-market Registry WG3Clinical Trials Infrastructure and Methodology WG4 Regulatory Convergence and Communication
Significance of Global Clinical Trial PMA
application
IDE
application
PMA
approval approval
application approval
Pre-IDE
meeting consultation
Clinical trial
consultation
consultation
Resolution of
the device lag
Conducted US-Japan joint clinical trials for two drug eluting stents
- ENDEAVOR（Medtronic Japan Co Ltd）
- XIENCE V（Guidant Japan KK（then））
Place of discussion needed on the issues associated with
conducting the joint clinical trial with single protocol
rarr WG1 has inherited duties
Collaborative Consultation and Review of Premarketing
Applications Pilot Program
bull The first drug eluting SFA stent both in the US and Japan
Global Clinical Trial Through HBD Activity
Contribute to the global device development by presenting proposed guidelines
through intensive discussions within SWG composed of experts in each ROI
bull Global clinical trial
bull Single protocol POC project
bull Virtual HBD
bull Discuss areas of interest
Scientific session
bull Discuss and formulate solutions for specific challenges in innovative device areas
bull Present specific recommendations for a single protocol Expert SWG
Scientific
session
SWG
POC
Project
HBD-WG1 Activity
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
GuidanceSuggestions ReportRequest
Working
Groups
HBD Structure
Steering Committee
MHLW
Industry
Academia
Regulatory
WG1Global Cardiovascular Device Trials WG2 Study on Post-market Registry WG3Clinical Trials Infrastructure and Methodology WG4 Regulatory Convergence and Communication
Significance of Global Clinical Trial PMA
application
IDE
application
PMA
approval approval
application approval
Pre-IDE
meeting consultation
Clinical trial
consultation
consultation
Resolution of
the device lag
Conducted US-Japan joint clinical trials for two drug eluting stents
- ENDEAVOR（Medtronic Japan Co Ltd）
- XIENCE V（Guidant Japan KK（then））
Place of discussion needed on the issues associated with
conducting the joint clinical trial with single protocol
rarr WG1 has inherited duties
Collaborative Consultation and Review of Premarketing
Applications Pilot Program
bull The first drug eluting SFA stent both in the US and Japan
Global Clinical Trial Through HBD Activity
Contribute to the global device development by presenting proposed guidelines
through intensive discussions within SWG composed of experts in each ROI
bull Global clinical trial
bull Single protocol POC project
bull Virtual HBD
bull Discuss areas of interest
Scientific session
bull Discuss and formulate solutions for specific challenges in innovative device areas
bull Present specific recommendations for a single protocol Expert SWG
Scientific
session
SWG
POC
Project
HBD-WG1 Activity
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Significance of Global Clinical Trial PMA
application
IDE
application
PMA
approval approval
application approval
Pre-IDE
meeting consultation
Clinical trial
consultation
consultation
Resolution of
the device lag
Conducted US-Japan joint clinical trials for two drug eluting stents
- ENDEAVOR（Medtronic Japan Co Ltd）
- XIENCE V（Guidant Japan KK（then））
Place of discussion needed on the issues associated with
conducting the joint clinical trial with single protocol
rarr WG1 has inherited duties
Collaborative Consultation and Review of Premarketing
Applications Pilot Program
bull The first drug eluting SFA stent both in the US and Japan
Global Clinical Trial Through HBD Activity
Contribute to the global device development by presenting proposed guidelines
through intensive discussions within SWG composed of experts in each ROI
bull Global clinical trial
bull Single protocol POC project
bull Virtual HBD
bull Discuss areas of interest
Scientific session
bull Discuss and formulate solutions for specific challenges in innovative device areas
bull Present specific recommendations for a single protocol Expert SWG
Scientific
session
SWG
POC
Project
HBD-WG1 Activity
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Conducted US-Japan joint clinical trials for two drug eluting stents
- ENDEAVOR（Medtronic Japan Co Ltd）
- XIENCE V（Guidant Japan KK（then））
Place of discussion needed on the issues associated with
conducting the joint clinical trial with single protocol
rarr WG1 has inherited duties
Collaborative Consultation and Review of Premarketing
Applications Pilot Program
bull The first drug eluting SFA stent both in the US and Japan
Global Clinical Trial Through HBD Activity
Contribute to the global device development by presenting proposed guidelines
through intensive discussions within SWG composed of experts in each ROI
bull Global clinical trial
bull Single protocol POC project
bull Virtual HBD
bull Discuss areas of interest
Scientific session
bull Discuss and formulate solutions for specific challenges in innovative device areas
bull Present specific recommendations for a single protocol Expert SWG
Scientific
session
SWG
POC
Project
HBD-WG1 Activity
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Contribute to the global device development by presenting proposed guidelines
through intensive discussions within SWG composed of experts in each ROI
bull Global clinical trial
bull Single protocol POC project
bull Virtual HBD
bull Discuss areas of interest
Scientific session
bull Discuss and formulate solutions for specific challenges in innovative device areas
bull Present specific recommendations for a single protocol Expert SWG
Scientific
session
SWG
POC
Project
HBD-WG1 Activity
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
改良モデルを用いた補完的国際共同治験
bull POC project Coronary debulking device
Original modelPMA approval
Complementary global clinical trial
with improved model
Improved model PMA submission
US clinical trial with original model
Validation of its efficacy and safety
Improved model
Shonin submission
Various Types of Global Clinical Trials 1
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
bull POC project EPC capture coronary stent
Shonin submission
PMA submission
US pivotal study
Japan and US
global clinical trials
FFR
OCT
Various Types of Global Clinical Trials 2
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
US Japan
10
Sapien XT
Zilver PTX
Atherectomy device from CSI
Combo Stent
Pivotal Study
Pivotal Study
Pivotal Study
Medical Environment
Compatibility Study
Pivotal Study（Global Clinical Trial）
Clinical Trial Designs Arranged For Various Development
Feasibility Study
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
11
HBD WG1-CLI-expert sub working group
11
Collaboration ie continuous discussion at HBD-WG1
SWG will facilitate timely development of medical devices
Conduct global clinical trial using
the same protocol in Japan and the US
bull Identify mutually agreeable points
bull Propose the outline of the clinical trial
taking into account the differences
between Japan and the US
bull Goal is to find unified approach
Survey on current situations
in Japan and the US
Identify and clarify differences
Understand what are already
practiced in each country
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
WG2Study on Post-market Registry
J-MACS（data entry started in 2010)
Participating
hospitals
Academic
societies
Data Base (Japanese Registry for VAD)
Data Center (DC)
Patient enrollment
Follow-up study
(data entry)
VAD companies
Malfunction reports
re-examinations
applications
Investigation
Information
Cooperation
Cooperation
Data access
(own companyrsquos)
CMS - Center for Medicare and Medicaid Services OSMB ndash Observational Safety Monitoring Board
DCC ndash Data and Clinical Coordinating Center UAB ndash University of Alabama at Birmingham
UNOS ndash United Organ Sharing Services DCR ndash Data Collection Repository
INTERMACS (in operation since 2006)
NIH FDA CMS
OSMB DCC
(UAB)
DCR
(UNOS)
SITES Sera Care
Steering
Committee
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
WG3Clinical Trials Infrastructure
and Methodology
Comparison of medical institutions between the US and Japan
As the results of educational training at the actual sites of global clinical trials
no real difference in level was found although some variances exist both in the US and in Japan
Cost study on clinical trials (published Japanese study results)
The First-ever Report on Multi-Company Survey of the Cost of Medical Device
Clinical Trials in Japan-Results of a Collaborative Study-
(Pharmaceutical and Medical Device Regulatory Science Vol 43 No5 2012)
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
3
ldquoin Regulatory Focus 2013 January
issue (RAPS)
in Regulatory Focus 2013 September
issue (RAPS)
WG4Regulatory Convergence and
Communication
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
ldquoAcceleratingrdquo Device Introduction
In Japan―Example with DESs
Cypher March 2004
Taxus express2 March 2007
Endeavor February 2009
Xience V January 2010
2005 2007 2008 2009 2010 2003
Cypher
select+ January 2010
Endeavor sprint January 2010
Nobori March 2011
Taxus Liberte January 2009
Taxus Element
2011 2012
Xience Prime April 2012
Resolute Integrity May 2012
2004 2006
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
bull Discussion between the regulators who have similar review is very important to maintain consistency of the required premarket data
bull More practical regulations will be possible through discussions based on the results obtained By Doing specific case studies (Importance of By Doing)
bull Cooperation of academia and industry is essential in implementing By Doing
bull The purpose is to share the results of and the lessons learned from By Doing (Ensure transparency)
What Wersquove Learned From ldquoBy Doingrdquo
It is the great advantage of HBD where academia industry and regulators can equally participate and practice rdquoBy Doingrdquo
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Approved MD
through this program
Zilver PTX Drug-Eluting
Peripheral Vascular Stent
The pilot program does not affect each Agencyrsquos ability to make its decision independently
Collaborative Review and Consultation
Pilot Program (from 2009)
bullFace to face meeting
bullTeleconference
bullE-mail
bullPre-IDE
bullPMA review
bullInquiry amp Response
MHLW
PMDA
Sponsor
3-ways
interaction
FDA
bullConsultation
bullShonin application review
bullInquiry amp Response
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
AchievementsLessons Learned from Collaborative Scheme
Communications between regulators and
applicants in the US and Japan have been enhanced
The quality of review process can be improved through the discussion between
the US and Japanese regulators whose review systems are very similar
Redundant studies can be eliminated by discussing the acceptable clinical
study designs in advance
It is now easier to create the situation where multifaced discussions among the regulators and the applicants of the US and Japan can be promoted thus benefiting both countries in terms of speed and quality of the review system
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
HBD has made a great contribution to solve the device lag in the cardiovascular area and to promote medical device development
1 Paved the way for the global clinical trials
Proved By Doing that conducting global clinical trials is possible
rarr Global clinical trial is now common for medical devices
2 Facilitated response to the medical devices to be developed in future
Provided an environment where academia industry and regulators can discuss in a timely manner
about the devices under development for which evaluation method has not been established
rarr Developed the guidance for CLI device evaluation
3 Promoted communications among all stakeholders
Deepened mutual understandings among stakeholders and clarified the issues rarr Cooperation from stakeholders to resolve the issue is now easily available
Achievements and Significance of HBD Activities
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Challenges and Future Role of HBD
bull High clinical trial cost in Japan rarr Improving bull Cardiovascular area ahead other areas bull US-Japan bilateral approach
Future Role of HBD
Please join in the HBD West 2014 Think Tank Meeting tomorrow
(September 19th) where we will discuss this topic
HBD has started to solve ldquodevice lagrdquo rarr Similarity of pre-market review process between the US and Japan was a key
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Make it GLOBAL
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention
Yuka Suzuki Ph D Director
Office of Medical Devices II PMDA
E-Mail suzuki-yukapmdagojp
For more information please visit our website
URL httpwwwpmdagojp httpwwwpmdagojpenglishinternationalharmonizationhtml
Thank you for your kind attention