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!