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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
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)
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
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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