PMDA Update: pIts current situation and future directionand future direction

Tatsuya Kondo, M.D. Ph.D.Tatsuya Kondo, M.D. Ph.D.Chief Executive

Pharmaceuticals and Medical25th Annual

Pharmaceuticals and Medical Devices Agency (PMDA), Japan EuroMeeting

4-6 March 2013RAI, Amsterdam

Netherlands

Disclaimer

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Contents

PMDA Update;PMDA Update;

Its current situation and future direction

1. Organization

2 A ti iti i M di i l P d t2. Activities in Medicinal Products

3. Activities in Medical Devices

4. International Activities

3

PMDA’s Safety Triangle

Unique Three-pillar System Securing Nation’s Safety

ReviewReduction in

Risk

Japanese CitizensJapanese Citizens

Safety ReliefR li f Safety

Continuous risk mitigation

efforts

Relief measures for health

damage caused by risk factors

4

efforts by risk factors

PMDA Staff Size

800

Ad i i t ti t751751

600

700Administrative part

Safety Department

ReviewDepartment

648648605605

678678

500

600 Review Department

Planned521521

426426

300

400 341341319319291291256256

200

256256

0

100

5

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Major Changes

Special Assistant for Chief Executive (Feb. 2012)Special Assistant for Chief Executive (Feb. 2012)

Office of Review Innovation (Apr. 2012)Office of Review Innovation (Apr. 2012)

Science Board (May 2012)Science Board (May 2012)

Director of Center for Product Evaluation appointed (June 2012)Director of Center for Product Evaluation appointed (June 2012)

Placed 2 Deputy Center Directors (June 2012)Placed 2 Deputy Center Directors (June 2012)

Reorganization of Office of Biologics (October 2012) Reorganization of Office of Biologics (October 2012)

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Organization Chart of PMDA

Office of Relief Funds

Offices of General Affairs / Office of Financial Management / Office of Planning and Coordination

Auditor

Auditor

Chief Relief Officer

Executive Director

Chi f R li f Offi

Chief Management Officer

Office of Review Administration

Office of Regulatory Science

Office of Standards and Guidelines Development

Associate Center

Director

Associate

AuditOffice

Chief Relief Officer

Office of Review Administration

Office of Review Management

Office of International Programs / International Liaison OfficersExecutive

Directorf C t

Associate Center

Executive Director

Chief

Office of Vaccines and Blood Products

Office of New Drug Ⅰ - ⅤExecutive Director

of Center for Product Evaluation Associate

Center Director

Center Director

Chief Executive

Office of Cellular and Tissue-based Products

Deputy Center Office of Vaccines and Blood Products

Office of Medical Devices Ⅰ-Ⅲ

Office of OTC/Generic Drugs

Associate Executive

DirectorDeputy Center Director

(for Cellular and Tissue-based

Products)

Office of Conformity Audit

Office of GMP/QMS Inspection Senior

Director

Principal Senior Scientist / Senior Scientists

Deputy Center Director

(for Medical Devices)

Office of Safety Ⅰ, Ⅱ

Office of GMP/QMS Inspection Executive Director

Chief Safety Officer

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Contents

PMDA Update;PMDA Update;

Its current situation and future direction

1. Organization

2 A ti iti i M di i l d t2. Activities in Medicinal products

3. Activities in Medical devices

4. International Activities

8

Review Time for New Drugs

Priority Review Products

FY 2008 FY 2009 FY 2010 FY 2011 FY 2012(As of Oct)

FY2012Target

15 4 11 9 9 2 6 5 6 1 9T t l R i Ti (M th) 15.4 11.9 9.2 6.5 6.1 9

Regulatory Review Time 7.3 3.6 4.9 4.2 3.9 6

Applicant's time 6 8 6 4 3 4 2 0 1 1 3

Total Review Time (Month)

Applicant s time 6.8 6.4 3.4 2.0 1.1 3

Standard Review Products

FY 2008 FY 2009 FY 2010 FY 2011 FY 2012(As of Oct)

FY 2012Target

22.0 19.2 14.7 11.5 10.0 12

Regulatory Review Time 11.3 10.5 7.6 6.3 6.0 9

Applicant's time 7 4 6 7 6 4 5 1 3 9 3

Total Review Time (Month)

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Applicant s time 7.4 6.7 6.4 5.1 3.9 3

Pharmaceutical Affairs Consultation on R&D Strategygy

Valley of Death -Short of funds, Knowledge on Regulation and development strategy, g g p gy

Strategic Consultation

Practical Use

Basic Research

Pharmaceutical and

Strategic Consultation 

Innovative Products originated from Japan

Pharmaceutical and Medical Devices

candidatesNon-

Clinical Study

Quality Study

Clinical Trial

Up to the levelf POC diStudy of POC studies

* Further studies are handled by the Regular

Consultation on quality or toxicity study of biologics,

Consultation on endpoints or sample size

Consultation

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y y gcell-and tissue-based products

p pof early clinical trial

Science Board

Science Board

Committee

・Committee members: External experts from Academia・Not involved in the Review Process of individual products

Recommendation on1. Review policy for innovative medical products2 Development of guidelines

Committee

2. Development of guidelines 3. Regulatory Science Research4. Personnel exchanges between PMDA and Academia5. Election of External review experts6 Improvements in the scientific aspects of review6. Improvements in the scientific aspects of review

Subcommittee

Deliberation on problems in each fieldCollaboration with PMDA working team (RS research, guideline development, etc.)

Cell- & tissue- Based products

Medical Devices

Pharma-ceuticals

Bio-basedproducts

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productsDevicesceuticals products

Promotion of personnel exchange

human resource developmentdevelopment

ReviewersNIHS

Universities and research institutions

Medical Institutions

Researchers

Outcome of researches Fostering of Regulatory

Scientist↓

Acquisition of innovative technologies

Speed up and improve

D l t d d d id li t l

Promotion of appropriate R & D

Speed up and improve product review

Develop standards and guidelines at early phase

Facilitate practical application of innovative technologiesg

Decrease drug /device lag

Improving Safety Measures

AnalysisCollection of Collection of InformationInformation

New Risk

InformationInformation

management system HypothesisHypothesisAssessment of

Safety measure ff t

Planning and Implementation of

Evaluation of Evaluation of hypothesishypothesis

effects

Safety measures

Crisis managementCrisis management

• Prevention of serious drug safety-related crisis from Japan

• Effective encouragement of proper drug use.

GoalGoal

• Ensuring credibility to post-market safety management system.

Contents

PMDA Update;PMDA Update;

Its current situation and future direction

1. Organization

2 A ti iti i M di i l d t2. Activities in Medicinal products

3. Activities in Medical devices

4. International Activities

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Medical Device

Procedure

M t i lMaterial

FIndication

Formtreatment

diagnostic

Medical Devices Regulation

EU Japan US Brazil Canada Singapore

Pre-market review

Notified bod

Class III, IV: Minister’s approval

Class III: PMAApproval Class III, IV:

Registro to ANVISA

Class II, III, IV: License from Health Canada

Class B, C, D: Registration to HAS

Notified body certification (requirements depend on device

Class II: Notified body certification

Class II: 510(k) clearance,

ANVISA

device classification)

Class I: Self-declaration

Class I: exemption

Class I, II: Cadastro to ANVISA Class I:

exemptionClass A:

exemption exemption exemption

Notified body review/certification Self declarationGovernmental approval/license

Harmonization By Doing (HBD)

• Activity between Japan and USA to develop global clinical trials and address regulatory barriers that may be impedimentstrials and address regulatory barriers that may be impediments to timely device approvals. (since 2003)

SteeringCommittee

FDA MHLW/PMDA DCRI JAG AdvaMed JFMDA

Report, RequestGuidance/Suggestion

Working

WG1:Global Cardiovascular Device TrialsWG2: Study on Post‐market RegistryWG3:Clinical Trials Infrastructure and Methodology

h k k ( l k )

GroupsWG3:Clinical Trials Infrastructure and MethodologyWG4: Regulatory Convergence and Communication

•HBD Think Tank East 2013 (July 8‐10, Tokyo, Japan)

J-MACS

Future partnership between Japan and the US

(US Registry: INTERMACS)

Contents

PMDA Update;PMDA Update;

Its current situation and future direction

1. Organization

2 A ti iti i M di i l d t2. Activities in Medicinal products

3. Activities in Medical devices

4. International Activities

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PMDA’s international activities

【PMDA International Vision: PMDA EPOCH】

1.Highest level of Excellence in Performance

2.Close Partnership with the Orient

3 Contribution to International Harmonization

Strengthen bilateral and multilateral relationship

3.Contribution to International Harmonization

Strengthen bilateral and multilateral relationship

Enhance human resource exchange / Cultivate employees with international minded and communication skills

Improve International PR activities / information transmission

Dissemination of Information

Review ReportReview ReportReview ReportReview Report

Safety InformationSafety InformationSafety InformationSafety Information

PMDA U d tPMDA U d tPMDA UpdatesPMDA Updates

News ReleaseNews Release

And more…And more…

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The First Indonesia-Japan Symposium

Date: February 13, 2013Venue: Jakarta IndonesiaVenue: Jakarta, IndonesiaFocus on: Pharmacovigilance and Good Distribution Practice

Organizers: Pharmaceuticals and Medical Devices Agency (PMDA)

Japan Pharmaceutical Manufacturers Association (JPMA）

National Agency of Drug and Food Control (NADFC)National Agency of Drug and Food Control (NADFC)

Gabungan Perusahaan Farmasi Indonesia (GPFI)

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3rd PMDA Training Seminar

2013 January 21-25

Post-Marketing Safety & Relief Servicesg y18 trainees from 6 countries: Korea, Taiwan,

Indonesia, Singapore, Brazil, Ukraine

Website: http://www pmda go jp/english/events/

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http://www.pmda.go.jp/english/events/3rd_pmda_training_seminar.html

Trainings for individual Trainees

Mid and short-term training

Medium-term trainingMay～July 2010: 2.5 months training for a SFDA reviewer

Dec 2011: Three weeks training for three KFDA officials on general issues

Feb 2012: One month training for TFDA (Taiwan FDA) officials on Medical Devices

Mar 2013: One week training for Indonesian NADFC officials on pharmaceuticals

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Dr. Kondo with Trainees from KFDA Dr. Kondo with Trainees from Taiwan FDA

To Improve Public Health

Review Safety Relief

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Th kThank you

ffor

tt ti !your attention!

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