The overview of PMDA activities

Atsushi TAMURA, Ph.D.

International Coordination Officer for Medical DevicesPharmaceuticals & Medical Devices Agency

Who are we? PMDA (Pharmaceuticals and Medical Devices Agency) is

Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.

Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.

We conduct scientific reviews of marketing authorization applications for pharmaceuticals and medical devices, monitoring of their post-marketing safety. We are also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.

PMDA’s Mission

To provide safer and more effective pharmaceuticals and medical devices as

fast as we can

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Philosophy of PMDA PMDA continues to improve the public health and safety of our nation by reviewing applications for marketing approval of pharmaceuticals and medical devices, conducting safety measures, and providing relief to people who have suffered from adverse drug reactions.

We conduct our mission in accordance with the following principles:

We pursue the development of medical science while performing our duty with greater transparency based on our mission to protect public health and the lives of our citizens.

We will be the bridge between the patients and their wishes for faster access to safer and more effective drugs and medical devices.

We make science-based judgments on quality, safety, and efficacy of medical products by training personnel to have the latest technical knowledge and wisdom in their field of expertise.

We play an active role within the international community by promoting international harmonization.

We conduct services in a way that is trusted by the public based on our experiences from the past.

[MHLW]Ultimate Responsibilities in policies & administrativemeasures

[PMDA]Science base review, examination, data analysis, etc. to assist MHLW’S measures

Our Responsibilities

PMDA three major functions/tasks

Relief Service for ADR and Other Infectious Disease

Review and Audit for Drugs/ Medical Devices Efficacy and Safety

Provision of Medical Expenses, Disability Pensions etc.

Relief Service for SMON, HIV-positive and AIDS patients

Clinical Trial Consultation

Conformity Audit for Application Materials of GLP,GCP and GMP/QMS

Information Provision (via the Internet), Pharmaceutical Consultation for Consumers

Post- marketing Safety Operations for Drugs / Medical Devices

Review of Efficacy and Safety

Reinforced Safety Information (Database)

Scientific Review and Research for Safety Information

PMDA (Phermaceuticals and Medical Devices Agency) was established in April, 2004 to ensure the following 3 tasks to protect public health.

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Key Organization Chart of PMDA

Office of Review Administration

Office of Review Management

Office of Medical Devices I - III

Office of New Drug I - V

Office of Biologics I - II

Office of OTC/Generic Drugs

Office of Conformity Audit

Office of Relief Funds

Office of Safety I - II

Office of Compliance and Standards

Offices of General Affairs/ Financial ManagementOffice of Planning and Coordination

Review Department

Post-marketing Department

（Inspections such as GLP/GCP and GPSP）

（GMP/ QMS Inspection)

Senior Executive Director

Chief Executive

Auditor

Auditor

Chief Safety Officer

Executive Director

Executive Director

Office of Reg. Sci. Operations

Office of International Programs

Chief Management Officer

Chief Relief Officer

Director(Center for Product

Evaluation)

7http://www.pmda.go.jp/english/about/organization.html

Contents

1. Organizational Updates2. Safety Measures3. PMDA International Vision4. Regulatory Science5. Science Board

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1. Organizational Updates

Staff SizeStrengthen Review System

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10

0

100

200

300

400

500

600

700

800

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Administrative part

Safety Department

Review Department

Planned

PMDA Staff Size

648605

521426

341319291256

678751

Strengthen Review System in PMDA-

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Special Assistant for Chief Executive (Feb. 2012)

Office of Review Innovation (Apr. 2012)

Science Board (May 2012)

2 Deputy Directors for Center for Product Evaluation (June 2012)

New Organization（as of June 2012）- Enhance partnership with academia -

Chief Executive

Relief Section

Executive Director

(Review・Research）

Director, Center for product evaluation

Administration Section

Deputy Center Director for medical Devices

Secretariat Director

Safety Section

Senior Executive Director

（Technology Management）

Review Section

Executive Director

（General Coordination）

Special Assistant

Deputy Associate director General

Associate director GeneralOffice of Review Innovation,

Director General

Deputy Center Director for Cellular-and Tissue-based products

Science Board

Subcommittee（Drug）

Subcommittee（Medical Device）

Subcommittee（biologics）

Subcommittee（cell-and tissue-based products）

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To reduce Drug Submission Lag

1. Promoting Global Clinical Trial• Developing Guidelines• Holding MRCT Workshop

2. Consultation • Pharmaceutical Affairs Consultation on R&D Strategy• Prior Assessment Consultation on Drugs

3. Efforts in Regulatory Science• Collaboration with Academia• Establishment of the Science Board• MHLW/PMDA/Academia Collaborative Study

2. Safety Measures

New Risk Management SystemElectronic Medical Record NetworkProject for Drug Safety

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New Risk management

system

AnalysisCollection of Information

Planning and Implementation of Safety measures

Hypothesis

Evaluation of hypothesis

Crisis management

• Prevention of serious drug safety-related crisis from Japan• Effective encouragement of proper drug use.• Ensuring credibility to post-market safety management system.

Goal

Assessment of Safety measure effects

Improving Safety Measures

Network of

the Collaborative

Hospitals

Collaborative Hospital

• Budget approved FY2011 Governmental to initiate “Safety 10Mil. Data project”• The network construction will be completed by FY2013.

Health RecordsClaim Data

Desired Outcomes:• Risk & benefit review of medical technologies to provide safer healthcare. • Quick and appropriate measures to ensure drug safety.

ResearchersJoint Study

Collaborative study

Data request

Collaboration

Quick actions Ordering Data Laboratory Data

Database

Database

Database

Database

EthicalCommittee

Database

Electronic Medical Record Network Project for Drug Safety

3. PMDA International Vision

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PMDA EPOCH TOWARD 2020

Concrete goals for PMDA to attain by 2020 as one of world’s premier medical products regulatory agencies

(Published in November 2011)

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PMDA International vision

- PMDA EPOCH toward 2020 -1. Excellence in Performance

2. Partnership with the Orient

3. Contribution to Harmonization

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4. Regulatory Science

MHLW/PMDA/Academia Collaborative StudyRegulatory Science CyclePromotion of Regulatory ScienceProgram of Collaborative Graduate Schools

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MHLW /PMDA /Academia Collaborative Study (MHLW FY 2012 Budget)

NIHS

366M yen (about $4.6M US) for;Developing guidance for innovative drug/medical device/biologics to streamline review process

Research Intuitions

Personnel exchangeSupport

MHLW

1.2B yen (about $15M US)Establishment of evaluation methods for safety and efficacy based on Regulatory Science Enhancement of personnel exchange among PMDA, Research Institutes, NIHS

Cultivate Human Resource

Develop Guidelines

Regulatory Science Cycle

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Data Acquisition

Evaluation &Estimation

Balancing Factors

Regulatory Action

Scientific Reflection

Advanced RS

For Developments Eying their Exits（Practical Use), for Rapid Processes Leading to Practical Use, and for Ensuring

the Efficacy and SafetyPromotion of Regulatory Science Research is Essential

Target for Drug

discovery

SeedsDiscovery

Lead compounds

IdentificationOptimization Non-clinical

Trial Clinical TrialLicense out to

IndustryDrug discovery by

Academia

R&D by IndustryValley of Death

Regulatory Science is seen as “Science that adjusts science technology outcome to it’s most favorable shape in harmonization between human and society ” that is an essential concept to prove risk/benefit and to ensure safety of pharmaceuticals and medical devices.

Promotion of Regulatory SciencePolicy recommendations released in 2011 Committee on Pharmaceutical of Science,

Science Council of Japan (August 19, 2011)

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Collaboration with Academia

Program of Collaborative Graduate Schools

Yamagata University

University of Tsukuba

Yokohama City University

Gifu Pharmaceutical University

Kobe University Chiba University

Musashino University

Agreement with 12 Universities (as of June, 2012)

Gifu University

Shujitsu University

Teikyo University

Shizuoka Prefectural University

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Osaka University

5 Establishment of the Science Board

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Why “Science Board” now?

① Provide review and consultation services with understanding of advanced technologies (antibody-based drugs, companion diagnostic drugs, ventricular assist devices, regenerative medicine, cancer vaccines, etc.).

② Provide consultation/advice on the advanced scientific technology from the early stage of development to deliver the medicinal products utilizing advanced technologies sooner to the medicinal scene.

③ Keep close relationship with the academia to have the PMDA reviewers updated to the accelerating innovation.

With Review Goal (Time) achieved andStaffers increasing, We at PMDA are required to:

Science Board26

Subcommittee

① Review policy for innovative medical products ② Development of guidelines ③ Regulatory Science Research ④ Personnel exchanges ⑤ Election of External review experts ⑥ Improvements in the scientific aspects of review

・ Deliberation on problems in each field ・ Collaboration with PMDA working team (RS research,

guideline development, etc.)

・・・・・・

Cell- & tissue- Based

products

Science Board

Medical Devices

Pharma- ceuticals

Mission Reform PMDA reviews and related services based on science with consideration for actual medical practices

Secretariat Director

Associate Director General

Secretariat Director’s office

Bio-based products

Director General

Office of Review Innovation

Committee

PMDA Offices

Science Board and Office of Review Innovation

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・Committee members: External experts from Academia

・Not involved in the Review Process of individual products

Review Safety

RS SGD

RS: Office of Regulatory ScienceSGD: Office of Standards and Guidelines Development

Academia

Board members

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

Office of Review Innovation

For PMDA To Be More Science-Based

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Pharmaceutical consultation on R&D Strategy

Basic Research

Seeds of new

drug / medical devices

originated in

Japan

Non-clinical tests

CTQuality 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

To Improve Public Health

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Review Safety Relief

Thank you for your attention!

Atsushi TAMURA, Ph.D.International Coordination Officer for Medical DevicesPharmaceuticals & Medical Devices AgencyJAPAN(独)医薬品医療機器総合機構 国際業務調整役（医療機器担当）

田村 敦史〒100-0013 東京都千代田区霞ヶ関3-3-2TEL 03(3506)9456 FAX 03(3506)9572

E-Mail: tamura-atsushi@pmda.go.jpURL: http://www.pmda.go.jp/

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