PMDAand

Application Procedures

Pharmaceuticals and Medical Devices Agency (PMDA)(PMDA)

Junko Sato1

The information within this presentation is based on the presenter’s expertise and experience, and represents

the views of the presenter for the purposes of a training workshop

ＷＨＡＴ‘Ｓ

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Our AgencyOur AgencyOur AgencyOur Agency

PMDA OfficePMDA OfficePMDA OfficePMDA Office

66thth –– 1111th Floorth Floor66th th –– 1111th Floorth Floor(Reception : (Reception : 66th Floor)th Floor)

ShinShin--Kasumigaseki Bldg. Kasumigaseki Bldg. 33--33--22, Kasumigaseki, Chiyodaku, , Kasumigaseki, Chiyodaku,

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, g , y ,, g , y ,Tokyo Tokyo 100100--0013 0013 JAPANJAPAN

History of Drug Review System in JapanHistory of Drug Review System in Japan1994 1995 1997 1999 2004 2008Commissioned new activities

to OPSR

Commissioned new activities

to JAAME

Establishment of PMDEC at NIHS

Establishment of PMDA

2001

to OPSR to JAAME

☆MHW ☆MHLW

☆PMDEC/NIHS☆PMDEC/NIHS

･Introduction of Team Review

☆OPSR (KIKO) ☆OPSR (KIKO)・Drug Equivalence Review

・GCP Inspection・Compliance Review・Clinical Trial Guidance ＰＭＤＡ

☆JAAME・Device Equivalence Review

Development of Human Resources （incl PMDEC OPSR JAAME)Development of Human Resources （incl. PMDEC, OPSR, JAAME)

89 (1994) 99 (1995) 121 (1996) 241 (1999)

←Doubled resource→b 3 l f

MHLW 61 pPMDEC 68 pOPSR 104 p

Note） Numbers indicated here stand for sum of the

3１１(2004)MHLW 58 pPMDA 253 p

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by 3 year plan from 1997

OPSR 104 pJAAME 8 p

officials of Drug and Device Review and Vigilance (including administrators & reviewers)

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Drug Development in JapanClinicalNon- Review Post-

g p p

（S h i )

PhaseⅠClinical Market

（Synthesis)（Preparation）（Pharmacology）

ININ PhaseⅡ ND

ND

（Toxicology)etc

ND

ND

PhaseⅢ

DA

DA

Ph ⅣPhaseⅣ

Pre P-I End of P-II

Pre NDAPre P-II

Pre PMC End of PMC

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Pre NDAPre P-II

Many chances to discuss with PMDAMany chances to discuss with PMDA

Numbers of PMDA consultations

450500

Application

350400450

ConductedWithdrawal

250300

100150200

050

100

0

FY2002

FY2003

FY2004

FY2005

FY2006

7

FY FY FY FY FY

From this April, New IND Scientific Consultation Process will be startedConsultation Process will be started– Increase numbers of meeting to meet a demand by

sponsorssponsors– Meeting in more timely manner

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NDA Review ProcessNDA Primary Meeting (Applicant & PMDA)

Inquiry & AnswerReview Report (1)Inquiry & Answer

Expert Discussion (External Expert & PMDA)

Inquiry & AnswerInquiry & AnswerInterview Review Meeting (PMDA E t l E t &

If necessaryIf necessary

S b it fi l PMDA i tS b it fi l PMDA i t

(PMDA, External Experts &Applicant ± specialists)

A l MHLW Council

Submit final PMDA review reportSubmit final PMDA review report

9Approval MHLW Council

(Pharmaceutical Affair and Food Sanitation Council)

MHLW

Thank you for your attention.

http://www pmda go jp/http://www.pmda.go.jp/

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