introduction to pmda’s international strategic plan 2015 › files › 000207782.pdf ·...
TRANSCRIPT
Introduction to PMDA’s
International Strategic Plan 2015
September 3, 2015
Dr Toshiyoshi TOMINAGA
Associate Executive Director for International Programs,
PMDA
2
Structure of the Strategic Plan
VISION
STRATEGY
ROADMAPS
4
VISION 2:To maximize the common health
benefits to othercountries/regions
VISION 1:To contribute
to the world throughregulatoryinnovation
VISION 3:To share the
wisdom with other countries/regions
Vision ITo contribute to the world through
regulatory innovation
Strategy 1:Taking the lead, and disseminating the
information around the globe
5
3rd Mid-term Plan 4th Mid-term Plan
In 3 yrs In 5 yrs
FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 ~ FY 2023
Taki
ng
the
lead
, an
d d
isse
min
atin
g th
e in
form
atio
n a
rou
nd
th
e gl
ob
e Regulatory Science Center
ProductReview
Post-MktSafety
Preparation Establish and operate Regulatory Science Center
Strengthen trainings on data analysis
Prepare and publicize guidelines and Points to Considers(Science Board, cross-product projects, designated projects, etc)
Begin full-scale use of cross-product
analysis to establish guidelines
Manage quality and upgradeMID-NET systems
Intensify cooperation and periodical discussion with overseas regulatory authorities / dissemination of information to overseas
Maintain MID-NET regularly (system upgrading as necessary)
Full-scale utilization for safety evaluation
Conduct pilot for cross-product analysis
Intensify cooperation and periodical discussion with overseas regulatory authorities / disseminate information to overseas
Pilot pharmacoepidemiologicalanalysis for safety evaluation
Plan 3rd party utilization process
Roadmaps to implement Strategy 1
3rd Mid-term Plan 4th Mid-term Plan
In 3 yrs In 5 yrs
FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 ~ FY 2023
Preparation Establish and operate
Regulatory Science Center
Regulatory Science Center
BIG DATA
Regulatory Science CenterRegulatory Decisions & Safety/Efficacy Estimation
on Next-Level Science
8
• New Guidelines
• Counsel on R&D
based on cross-
product analysisNDA Data
(indiv. clin. data, etc.)
Medical Records(MID-NET, etc.) • Risk Evaluation
with Pharmaco-epidemiological ground
Vision II:To maximize the common health
benefits to other countries/regions
Strategy 3:Increase efficiency of inspections that may lead to future international work-sharing
9
Strategy 4:Contribution to international regulatory
harmonization activities
Strategy 2:Promotion of international regulatory harmonization and global cooperation
Work-sharing for efficiency (Strategy2, 3)
3rd Mid-term Plan 4th Mid-term Plan
In 3 yrs In 5 yrs
FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 ~ FY 2023
Incre
ase
effic
ien
cy o
f in
sp
ectio
ns GMP
QMS
GLP
GCP
Strengthen PIC/S activity
Promote up-skilling of inspections / conduct of co-inspections
Promote equalization of inspection skills within OECD
Conduct co-trainings and inspections with Asian Regulatory Authorities
Strengthen MDSAP activity
Review report exchanges
Set up a platform for GCP cooperation
Review report exchanges
Take steps towards MRA sign-offs
Plan a model for mutual use of US/EU/Japan inspection results
Conduct workshops in emerging countries, and promote mutual acceptance of inspection results
Roadmaps to implement Strategy 3
Actively lead OECD/GLPas a chair
RHSC
/GLP
International Harmonization (Strategy 4)
Vision III:To share the wisdom with other
countries/regions
Strategy 5:Provision of information and training
programs that are essential for building regulatory capacity in partner countries
13
3rd Mid-term Plan 4th Mid-term Plan
In 3 yrs In 5 yrs
FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 ~ FY 2023
Asi
anTr
ain
ing
Cen
ter Establish and
operate
Conduct training programs for pharmaceuticalsand medical devices
Contribution to capacity building in AsiaProvision of post-marketing safety information
Programs held in Japan: Prepare and conduct basic and intermediate training programs (advanced training programs prepared on an individual basis)
Program held in key ASEAN countries: Prepare basic and intermediate training programs
Disseminate safety information in English, and respond to queries from Asia
Overseas: Conductpilot (intermediate)
Overseas: Conduct periodical program (basic)
Establish and operate Asian Training Center
Overseas: Conduct periodical programs
(intermediate)
Contribute to capacity building in Asia through activities such as APEC
Overseas: Conduct pilot
(basic)
Overseas: Select sites and discuss
how to proceed
Prepa-ration
Roadmaps to implement Strategy 5
3rd Mid-term Plan 4th Mid-term Plan
In 3 yrs In 5 yrs
FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 ~ FY 2023
Establish and operate
Conduct training programs
Japan: Prepare and conduct basic and intermediate programs(advanced training programs prepared on an individual basis)
Prepare basic and intermediate training programs
Conduct pilot (intermediate)
Conduct periodical programs (basic)
Establish and operate Asian Training Center
Conduct periodical programs
(intermediate)
Conduct pilot
(basic)Select sites and discuss how to
proceed
Ove
rsea
s
Prepara-tion
New Office Established on August 25
Asian Training Center
Conduct training courses in partner
countries
Expand training courses in Japan
PMDA builds solid foundation forinternational operation
日本語
English
Cooperation &
Harmonization
Excellence in Reg. Science
Capacity
Building
Fruitful International Activities
Cooperation &
Harmoni-zation
Excellence in Reg. Science
Capacity Building
Fruitful International Activities
Cooperation &
Harmoni-zation
Excellence in Reg. Science
Capacity Building
PMDA of the world, for the world.
Thank you for your attention!