2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China

Current Challenges and

Initiatives of the PMDA

Kyoichi Tadano, Ph.D.

Pharmaceuticals and Medical

Devices Agency (PMDA)

2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China

Agenda1.Current Picture of the PMDA

・Our philosophy

・Responsibilities of MHLW & PMDA

・Organization

2. PMDA’s New Goals & Challenges

Outline of Second Mid-term Plan(FY2009~2013)

3. Message from the PMDA

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Our philosophy

- 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.

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Our philosophy- 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.

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

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Responsibilities of MHLW and PMDA[MHLW][MHLW]

Planning basic policy, enforcement of administrative measures, such as approval, administrative order, etc which are based on the PALex. ・・・・ Final judgment on approval

・・・・ Directions of withdrawal and issuance of emergency

safety information

・・・・ Safety measures for emergent and significant cases

[PMDA][PMDA]

Implementation of work, such as review, examination, data analysis, etc before administrative measuresex. ・・・・ Scientific review of Pharmaceuticals and Medical Devices

GLP/GCP/GMP/QMS inspection, Clinical trial consultation

・・・・ Collection, examination, analysis, assessment and

provision of ADR information

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Location of the PMDA & MHLW

MHLWMHLWMHLWMHLW

Imperial palace

The Diet

Kasumigaseki Kasumigaseki

10 min. walk

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PMDA 3PMDA 3 major work areasmajor work areas

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 and HCV positive and HC positive

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

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Office of Review Administration

Office of Review Management

Office of Medical Devices ⅠⅠⅠⅠ,ⅡⅡⅡⅡ

Office of New Drug ⅠⅠⅠⅠ～～～～ⅤⅤⅤⅤ

Office of Biologics ⅠⅠⅠⅠ, ⅡⅡⅡⅡ

Office of OTC/Generic Drugs

Office of Conformity Audit

Organization Chart of PMDA Organization Chart of PMDA as of April 2010as of April 2010

Office of Relief Funds

Office of SafetyⅠⅠⅠⅠ, ⅡⅡⅡⅡ

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

Number of regular staff members: 605 (as of April ‘10) with ca.900 external experts

Office of RS Operations

Office of International Programs

Chief Management Officer

Chief Relief Officer

Director(Center for Product

Evaluation)

From April 2009

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2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China

Agenda1.Current Picture of the PMDA

・Our philosophy

・Responsibilities of MHLW & PMDA

・Organization

2. PMDA’s New Goals & Challenges

Outline of Second Mid-term Plan(FY2009~2013)

3. Message from the PMDA

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PMDA’s New Goals & ChallengesSecond Mid-term plan（（（（FY2009～～～～2013））））

1. Eliminate the issue of “Drug Lag /Device Lag”to a level comparable to that in EU and the U.S.

2. Improve safety measures for ensuring public safety and reassurance

3. Advance Regulatory Science

4. Improve and Strengthen International Programs

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- Advance Global Clinical Trials

- Strengthen review system and Improve

consultation

- Set review time goals

→ Provide patients with the world’s latest

Pharmaceuticals and Medical Devices in a speedy manner

1. Eliminate the issue of “Drug Lag/Device Lag” to a level comparable to that in EU and the U.S.

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Governmental Initiatives• 5-year Strategy for the Creation of Innovative

Pharmaceuticals and Medical Devices- Measures aiming for development of drugs originating in

Japan and Japan’s participation in simultaneous global

development

• 5-year Plan for Clinical Trials Activation- Designation of 10 Core Clinical Research Centers

(CCRCs) and 30 Major Clinical Trial Institutions (CTIs) etc.

• Action Program for Acceleration of Medical Device Review- Increase of reviewers

- 3-track system etc.12

PMDA initiatives for promoting Global Development

� “Publication of Basic Principles on Global Clinical Trials “ Published on September 28th, 2007

� “ Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drug” Published on April 17th, 2008

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Promote Global Clinical Trial

Clarify Review criteriaGlobal CTClarify review criteria

Target review time development time

→→→→ 1.5 year reduction

approval review time

→→→→ 1.0 year reduction

Introduce

prior assessment /

Improve consultation

Increase the number of reviewers /

Enhance training

FY2008FY2007

Action program on New Drug ReviewsAction program on New Drug Reviews

Increase reviewers by 236

Introduce Integrated training program

Improve training

Improve the quality and quantity of consultations

Improve consultationmenuintroduce Prior assessmentat development stage

Number oftotal

consultations1200 cases

Total Review Time (median) FY 2011Standard: PMDA/MHLW 9 mos.+ Applicant 3mos.→→→→ 12 mos.

Priority : PMDA/MHLW 6 mos.+ Applicant 3 mos.→→→→ 9mos.

FY2007 FY2008 FY2009 FY2010 FY2011

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Recruitment situation of PMDA

• Increasing the size of review staff of PMDA for

the faster and better review

# of April April April April April April April End of

Staff 2004 2005 2006 2007 2008 2009 2010 FY2013

PMDA

Total

256 291 319 341 426 521 605 751

(planed)

Review

Staff

154 178

(+24)

197

(+19)

206

(+9)

277

(+71)

350

(+73)

389

(+39)

….

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- Develop predictive and preventive safety measures by improving of analytical estimation system of ADR reports

- Offer integrated services ranging from clinical trial consultations and approval reviews to post- marketing safety measures

- Increase the number of staff in the Office of Safety by 100 until FY 2010

２２２２．．．．Improve safety measures for ensuring

public safety and reassurance

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Safety TriangleTotal Risk Management through three work areas

PublicSafety

Continuous Risk Reduction

Review

Relief

Relief for ADR

Risk Containment

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3. Advance Regulatory Science

- “Regulatory Science” is defined as the scientific study for implementation of regulation and administrative policy based on up-to-date knowledge of life science and advanced scientific research.

- Promulgate regulatory science by promoting the Joint Graduate Studies Program, research exchange and information provision.

- Cooperate on the development of infrastructures for clinical research and clinical trials at clinical practices site

→→→→ “Significance of Regulatory Science”

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Being at the FOREFRONT of :

- Technology

- Science

- Producing New Era of Molecular Medication

More sophisticationMore integration ⇒⇒⇒⇒ Into Regulatory SystemMore combination

⇒⇒⇒⇒Lead regulatory framework ⇒⇒⇒⇒Need to coordinate ⇒⇒⇒⇒Further Modernization

Creation of “Regulatory Science” is critically important to the PMDA’s mission

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Regulatory Science:

We must conclude Scientific Judgment that meets many complicated factors

DrugsMedical Devices

Laws & Ordinances Others

A

B

C

E

Fast access Safety

Sovereign Interests Globalization

Latest Science & Technology

PMDA

Factor

C Risk Benefit

D

Economic Interests Social Interests

FG

H

・・・・・・・・

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Introduction of Collaborative Graduate Studies Program

PurposeTo attract excellent reviewers and provide the field of clinical

research with experienced staff learned Regulatory Science

• Collaborative Graduate Studies Program• A lot of case studies of latest clinical data package

(new Drug reviews)• Participation in International conferences and major

clinical academic meetings• Discussion with global companies who has a lot of

experiences

Post graduate clinical

training

Doctoral

course

Take a doctorate degree

Core personnel in charge of clinical research

of each medical institution

ＰＭＤＡＰＭＤＡＰＭＤＡＰＭＤＡ

Career Path program (example for a physician)

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4. Improve and Strengthen International Programs

PMDA discussed with MHLW how to implement

international activities for pharmaceuticals and

medical devices in future, and formulated a

framework for international activities with

the following aims:

(1) Further strengthening of partnerships with regulatory agencies in the US and the EU

(2) Creation of partnerships with regulatory agencies in Asian countries such as information exchanges

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(1)Further strengthening of partnerships with regulatory agencies in the US and the EU

• Rapid exchange of a wide range of information through the promotion of executive-level talks with the US FDA and the EMA and the dispatch of manager-level resident officers to these agencies.

• Maintenance and development of initiatives led by Japan, the US, and the EU, including the ICH.

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(2) Creation of partnerships with regulatory agencies in Asian countries such as information exchanges

• Strengthening of cooperation with China and Korea through meetings such as Director-general level meetings concerning pharmaceutical affairs.

• Promotion of information provision and the acceptance of trainees in line with the needs of regulatory agencies in Asian countries.

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PMDA International Strategic PlanPMDA International Strategic Plan was formulated in

February 2009, which outlines the basic policies for

overall international activities; Targets to be achieved during the second mid-term plan period (FY2009-2013):

1. Strengthen cooperation and build collaborative relations with the US, the EU, Asian countries, and relevant international organizations

2. Participate in international harmonization

activities and further contribute to such activities

3. Improve and strengthen information provision

to overseas countries

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Our Challenge ：：：：Building of collaborative relations

US/FDA

Other Main Countries：：：：Canada / Australia

International Organizations：：：：

WHO,OECD

PMDA /MHLW

HBD

EC/EMA

Asia

ICH, GHTFBilateral meeting

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We must work in accordance with International standards

・Bilateral and executive-level talks with US FDA,

EC/EMA periodically

・Dispatch manager-level resident officer to Washington DC and London for a long term

・Information sharing based on confidentiality agreements

International standards = Based on “Regulatory Science”

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4th International Summit（（（（October 2009））））

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DIA Annual & Bilateral Meetings（（（（June 2008））））

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22nd DIA EURO Meeting（（（（March 2010））））

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Asian Regulatory Cooperation

April 2007 1st Tripartite Health Ministers Meeting (China/Korea/Japan)

April 2008 1st Tripartite Director-Generals Meeting (China/Korea/Japan)

April 2008 1st East Asian Regulatory Symposium Nov. 2008 2nd Tripartite Health Ministers MeetingJan. 2009 MOU (China SFDA & Japan MHLW)Aug. 2009 1st Working Group(China/Korea/Japan)Nov. 2009 3rd Tripartite Health Ministers MeetingDec. 2009 2nd Working Group(China/Korea/Japan)

2nd Tripartite Director-Generals MeetingThe Drug Clinical Trial Symposium

For Strengthening Regulatory Cooperation in East Asian countriesFor Strengthening Regulatory Cooperation in East Asian countries

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3rd Tripartite Health Ministers Meeting（（（（November 2009)

1. Clinical Research

We welcomed the progress of cooperation in an area of clinical research, including

that made through holding of meetings of the heads of pharmaceutical-related

bureaus of the participants. This progress was made after the first THMM, which

impressed us with the importance of cooperation among the three countries in the

area of clinical research including clinical trials. We reaffirmed the importance of

tripartite cooperation in clinical research. 32

2nd WG & Tripartite Director-Generals Meeting

(December 2009)

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The agreement-Terms of Reference of the WG.

⇒defines WG’s objectives, projects to work on, procedures,

participants, and other rules.

- Two projects the WG conducts are:

(a)research on ethnic factors in clinical data from three countries,

(b) information exchange on drug clinical trials.

- The research project on ethnic factor concerns itself primarily

with PK data from the three countries. ⇒ MHLW/PMDA, a coordinator of this project, will propose

a detailed work plan to WG.

- Next WG and DG meeting ⇒Hosted by KFDA, September, 2010 in Seoul

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Japan-China Bilateral Relationship

• MOU concluded in January 2009– Cooperation on Drugs, Devices and Cosmetics– Information Exchange (not confidential)

– Dialogue on Important Issues on Laws, Regulations and Related Issues

– Compare and Assess their differences in regulatory or legal approaches, to explore possibilities for co-operation in the field of dissemination of standards

• Bilateral Meeting in April & December 2009– Acceptance of trainees– Future Cooperation

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2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China

Agenda1.Current Picture of the PMDA

・Our philosophy

・Responsibilities of MHLW & PMDA

・Organization

2. PMDA’s New Goals & Challenges

Outline of Second Mid-term Plan(FY2009~2013)

3. Message from the PMDA

36

EUEU North AmericaNorth America

USAUSA

CanadaCanada

JapanJapan

KoreaKorea

ChinaChina

SingaporeSingapore

AsiaAsia

Drugs from Asia to the world

Asia plays a very important role in global drug development 37

Industry

Regulatory Authorities

Academia

The People

Work together in a responsible manner based on regulatory science

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Future Asian Collaborations

will provide

effective & safe drugs quickly to all patients in Asia

PMDA requests your great cooperation for Asian Patients

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Organized by PMDA / JPMA / CCPIE,

Associated by RDPAC

2010 China-Japan Symposium on

Global Clinical Trials and Ethnic Factors

Date / Time: Friday, May 28, 2010 / 9:00-17:40Venue: JW Marriott Hotel Beijing

Jianguo Road, China Central Place, Chaoyang District, Beijing, 100025, China

– Simultaneous Translation between Chinese and Japanese available –

Please forward Registration Form to CCPIE by May 20, 2010. Registration Fee： RMB 1000 Yuan for 1 person

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Thank you for your attention !

http://www.pmda.go.jp/tadano-kyoichi@pmda.go.jp

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