PMDA’s effort to accelerate medical devices development‐Introduction of PMDA’s development support systems

Yusuke HashimotoReviewer, Pharmaceuticals and Medical Devices Agency,

Office of Medical Devices I

Today’s Topics

• Introduction• What is “Device Lag”?• Acceleration of Medical Devices development• Overview of PMDA’s development support systems

Review Teams for MDs/IVDs

OMD I & II:New/Improved Device Teams 1-8

OMD III:Me-too Device

Teams 1-8

Team 1 Field of ophthalmology, otorhinolaryngology

Team 2 Field of dentistry

Team 3 Field of neurosurgery, cardiology, vascular surgery, respiratory

Team 4 Field of neurosurgery, cardiology, vascular surgery, respiratory (electronic devices)

Team 5 Field of gastroenterology, urology, gynecology

Team 6 Field of orthopedics, plastic surgery, dermatology

Team 7 In vitro diagnostic medical devices

Team 8 Others

Quantitative Increase and Backgroundof Medical Device Reviewers

AP started

What is “Device Lag”

• “Device Lag” means the period of lag between US Approval of medical devices and Japan Approval

USExamination period

Application Approval

Application ApprovalJapanExamination periodApplication Lag

Post‐application Lag

Device Lag

Review Times for Medical Devices

Category FY 2010 2011 2012 2013 2014

New（80% tile) 92.9% 100% 98.4% 90.2% 31.3%

Improved (w clinical data, 60%tile) 100% 100% 97.6% 82.6% 17.0%

Improved (w/o clinical data, 60% tile) 99.4% 98.8% 99.0% 94.2% 38.3%

Generic (60% tile) 98.9% 98.8% 98.2% 93.8% 63.9%

Completion rate

21.6

17.8

15.5 14.8

10.6

17.5 1819.8

13.2

10.5

17.314.9

11.1

9.27.4

15.1

7.2

6 5.3 4.5

0

5

10

15

20

25

2010 2011 2012 2013 2014FY

What is “Device Lag”

• “Device Lag” means the period of lag between US Approval of medical devices and Japan Approval

USExamination period

Application Approval

Application ApprovalJapanExamination periodApplication Lag

Post‐application Lag

Device Lag

8

Pharmaceutical Affairs Consultation on R&D Strategy

Practical Use

Innovative Products

Basic ResearchPharmaceuticals and

Medical Devices candidates

Non-Clinical Study

Quality Study

Clinical Trial

Valley of Death -Shortage of funds, Knowledge on Regulation and developmental strategy

（Up to POC studies）

* Further studies are handled by the Regular Consultation

Consultation on quality and battery of pre‐clinical, including examining tumorigenicity,

biological ingredient safety

Consultation on endpoints or sample 

size of early clinical trial

Strategic Consultation 

Introductory Consultation(684)

Pre‐Consultation(813)

Face‐to‐Face Consultation(209)

Flow of Strategy 

Consultation (7/1/2011 – 6/30/2014)

Initiative to facilitate development of innovative drugs, medical devices and cellular and tissue‐based products

• Support establishment of evaluation system for safety and efficacy with R&D as the basis at research facilities researching technology

• Enhance human resources between universities, NIHS, PMDA, and train resources adept in RS

PMDA, NIHS, etc Academia

Dispatch reviewers

Accept researchers

Research Results

Early development of standards and/or guidelines, etc

Promote implementation of innovate technologies

(Eliminate drug lag and device lag)

Human resource development by personal exchange

Learn innovative technologies

Accelerated higher quality review

Develop regulatory science experts

Promote proper R&D

Establishment of the Science BoardThe Science Board was established in May 2012 to discuss how PMDA can better cope with products with advanced science & technology, in each developmental stage such as basic research, development support, product review, and post market safety measures. 

Office of Review Innovation

Pharmaceutical consultation on R&D 

Strategy

Basic Research

Seeds of new drug / medical devices

Non‐clinical tests

Clinical TrialQuality Tests

Practical use

Innovative medical products

Offices of Review (Drugs & Medical Devices), Office of Safety

Clinical Trial Consultation Review

Review ApprovePost 

Marketing

Post Marketing Safety Measure

Board members 

Academia (Knowledge of the Latest Innovative Technologies)

Establishment of Science Board

10

PMDA’s Consultation Menu

Pre-development consultation

Quality Consultation

Safety Confirmation Consultation

Consultation on Performance Test

Consultation on Clinical Evaluation

Exploratory Clinical Trial Consultation

Application Procedural Consultation

Clinical Trial Consultation

Pre-applicationConsultation

Very early stage Non-Clinical CT required? CT Pre-applicationM

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Pharmaceutical Affairs Consultation on R&D Strategy

Prior Assessment Consultation

Dev

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PMDA’s Consultation

Number of consultation for medical devices

FY2010 FY2011 FY2012 FY2013 FY2014

106 140 168 173 207

FY2010 FY2011 FY2012 FY2013 FY2014

- 6 5 38 16

Number of pharmaceutical affairs consultation on R&D Strategy for medical devices

Further Collaboration with Industry

To further shorten the development period, we need ・・

・Applicant’s cooperation - appropriate evaluation of the devices- suitably-preparation of application documents

・Oversea manufacturer’s cooperation- giving accurate information to Japanese distributors- quick response to inquiry from Japan

・Joining the meeting with PMDA in early stage

Thank you!!

http://www.pmda.go.jp/