Global Drug Development in China What e can do?-What we can do?

Chen XiaoyuanChen XiaoyuanCenter for Drug Evaluation(CDE) Center for Drug Evaluation(CDE)

State Food and Drug Administration(SFDA)State Food and Drug Administration(SFDA)

S 30 2008 T k

S g A (S A)S g A (S A)P.R.ChinaP.R.China

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Sep 30 ,2008, Tokyo

DisclaimerDisclaimer

The opinions included herein are those ofThe opinions included herein are those of

the presenter, and do not necessarily p , y

reflect those of the CDE ,SFDA

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OutlineOutline

Chi ’ d d i i t ti tChina’s drug administration system

Global drug development in China

How to share the knowledge amongHow to share the knowledge among regulatory agencies in Asian region

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China’s Drug Administration SystemChina’s Drug Administration SystemChina s Drug Administration SystemChina s Drug Administration System

Ministry of Health (MOH )

SFDA31 Provinces

DDR CDEPFDA

DDSI

NICPBP

CDRPIDC

CDCNICPBP

SPCCDDR: Dept of Drug RegistrationDDSI: Dept of Drug Safety and Inspections

CDC: Center for Drug Certification SPCC: State Pharmacopoeia Commission of China

CDC

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p g y pCDR: Center for Drug Re-evaluationNICPBP: National Institute for the Control of

Pharmaceutical & Biological Products

pPFDA: Provincial Food & Drug AdministrationPIDC: Provincial Institute for Drug Control

Main Responsibility of Main Responsibility of p yp yCDECDE

Technical Evaluation of Drug ApplicationsTechnical Evaluation of Drug Applications•• Both IND and NDABoth IND and NDA

•• Chemical products, biologic products, including vaccines, andChemical products, biologic products, including vaccines, andChemical products, biologic products, including vaccines, and Chemical products, biologic products, including vaccines, and

TMC , including botanical drugsTMC , including botanical drugs

Ad i i t ti i d l t ith SFDA d t tAd i i t ti i d l t ith SFDA d t t•• Administrative review and approval stay with SFDA department Administrative review and approval stay with SFDA department

of drug registrationof drug registration

•• PostPost--marketing review stays with Center for Drug Remarketing review stays with Center for Drug Re--evaluationevaluation

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CDE organizational Structure

•Director of CDE

C o ga at o a St uctu e

•Deputy DirectorMs. Du xiaoxi

•Deputy DirectorMs Zhang Peipei

•Director of CDEMr Li Guoqing

•HR

•Information Service

•Office 1 •Office2 •Office 3 •Office4 •Office 5

•Finance

•Adm. & Coordination

•Division 1

•Division 2

•Division3

•Division 4

•Division 5

•Division6

•Division 7

•Division 8

•Division 9

•Division 10

•Administrative Div•Division of Bio-productTCM TCM Chemical Drug

InfectionRespiratory

Ophthalmology

Chemical DrugCV&nephrosis

CNSSurgery Chemical Drug

•Training & CoordinationOphthalmology

ENTDermatology

SurgeryNutrition

Chemical DrugOncology

Gynaecology GI

EndocrineR di ti

6*TCM: Traditional Chinese medicine Radioactive

Biotechnical drug

Project TeamProject Teamjj

Project ManagerProject Manager

senior reviewersenior reviewerProject Project

Discipline Discipline reviewerreviewer

TeamTeam

P j t t i b i i itP j t t i b i i it

(CMC,non(CMC,non--clinical,clinical)clinical,clinical)

•• Project team is basic review unitProject team is basic review unit•• Each Project team for each indicationEach Project team for each indication•• 44--6 fixed members including 6 fixed members including CMC,nonCMC,non--clinical,clinical reviewer*clinical,clinical reviewer*

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gg ,, ,,

*More reviewer can be involvedreviewer can be involved from different offices if needed

D i i ki PDecision-making Process

C t Di tCenter Director SFDA(administrative approval)

OfficeCDE

( d l i )Division

( drug evaluation)

Team PFDA/SFDA*(filing/format review)

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( g )

*for domestic application, the dossier should be submitted to PFDA; while for the import application ,directly to SFDA office.

Global Drug Development in China

E i k t i A i i l di ChiEmerging markets in Asia, including China are playing more and more important role in global drug developmentdrug development• High growth rate of sales market share• R&D center investment in past of 5 years • Trend to include Asian emerging markets in Trend to include Asian emerging markets in multinational clinical trial

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Multinational Clinical Trials in China 2002~April 2008Multinational Clinical Trials in China 2002~April 2008

72 7470

70

80roved

61

53

50

60

70ation/appr

application

19

31

1820

30

40

of applica application

approved

3

1013

3

0

10

20

2002 2003 2004 2005 2006 2007 2008

numbers

2002 2003 2004 2005 2006 2007 2008

year

10

No. of Ph II/III of Multinational Clinical TrialsNo. of Ph II/III of Multinational Clinical Trials

phase II, III

118120140

6080

100120

phase II, III

17204060

p ase ,

0phase II Phase III

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R&D Center Investment In China

12Data source: Zhang Wei, DirectorData source: Zhang Wei, Director--General of Department of Drug Registration, SFDA at General of Department of Drug Registration, SFDA at

East Asian Pharmaceutical Regulatory Symposium ,Tokyo, Japan, April 14-15,2008

OpportunityOpportunityViews from industry

For IND• Review time too long to participate simultaneous global development

For NDA •“Drug lag”: Many drugs are available in China 3-4

ft it i iti l l i th US d Eyears after its initial approval in the US and Europe

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Review Time for Multinational Clinical TrialsReview Time for Multinational Clinical Trials

10087

4860

80

100

review

10

48

20

40

60

umbers of

10

0

20

<4m <7m >7m

nu

review time

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Challenges at CDE:Challenges at CDE:Increasing workload & limited resourceIncreasing workload & limited resource

15Source Data: Dr. Zili LI, Merck & Co, Inc at CMR Conference, December 4, 2007

Capability Issue

•Lack of internal statisticians•Limited number of medical reviewers：responsible for•Limited number of medical reviewers：responsible for statistics ,clinical pharmacology review, as well as act as project manager•Insufficient experience in evaluating innovative drug•Advisory Committee for each therapeutic area should b b tt i dbe better organized

39%22%

CMC39%

16%23%

CMC

non-clinical

clinical

others

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16%

How to share the knowledge in Asian RegionAsian Region

Limited human resource and capability have been a dilemma for many other regulatorybeen a dilemma for many other regulatory agencies in Asia.

Possibility of cooperation in Asian regionPossibility of cooperation in Asian region

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19

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Share resourceShare resourceShare resourceShare resource

Sharing review resource, such as exchange Sharing review resource, such as exchange review reports among differentreview reports among differentreview reports among different review reports among different countries/regions to decrease duplication in countries/regions to decrease duplication in assessment assessment Clinical data mutual Clinical data mutual acceptanceacceptance to avoid to avoid unnecessary clinical trialunnecessary clinical trialyyDeveloping cooperation clinical research in Developing cooperation clinical research in special area special area pp

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Sh i f t d t d i li i l i d d

Share experienceSharing safety data during clinical period and post-marketing, site inspection to enhance risk

tmanagementPeriodical discussion for some common issues to reach agreementExchange review staffs and joint trainingExchange review staffs and joint trainingg j gg j gCDE ongoing program: Hongkong, Macaw, CDE ongoing program: Hongkong, Macaw, TGA WHOTGA WHO，，TGA, WHOTGA, WHO，，

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Information platform developmentp p

Electronic submissionElectronic submission ee CTDCTDElectronic submission Electronic submission ––ee--CTDCTDReview report template,Review report template,Clinical trial information network,Clinical trial information network,Safety information networkSafety information networkSa e y o a o e oSa e y o a o e o

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conclusionconclusionGl b l d d l t b ht b thGl b l d d l t b ht b thGlobal drug development brought us both Global drug development brought us both

opportunity and challengeopportunity and challenge

Regulatory agencies in Asian region need to cooperate to make the best use of limitedcooperate to make the best use of limited resources and provide efficient and rapid access to new therapies whilst protecting patient safetynew therapies whilst protecting patient safety

Exploring appropriate cooperation model underExploring appropriate cooperation model under current regulatory system

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FutureFuture

GOOD GOOD UNDERSTANDING,UNDERSTANDING,BETTER BETTER COOPERATION!COOPERATION!COOPERATION!COOPERATION!

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Future

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Website: www//CDE.ORG.CN

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