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1 1
2 2
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5 EU5 20.3% Source: IMS Health, IMS MIDAS, MAT Dec
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10 FDA 10
11
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13 13
14 2.5
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17 PMDA 17
18 18
19 2009 Office of International Programs PMDA upmda u u u 19
20 20
21 ICH JAPAN MHLW/PMDA JPMA Observer: WHO, Health Canada, EFTA Secretariat: IFPMA EU EC/EMEA EFPIA USA FDA PhRMA Steering Committee (SC) Expert Working Group (EWG) Quality Safety Efficacy Multidisciplinary Implementation Working Group:Q&A for Guidelines
22 Outcome of ICH - Over 50 ICH Guidelines - Topics / guidelines Quality Safety Efficacy Multidisciplinary 10 topics / 24 guidelines 8 topics / 13 guidelines 14 topics / 19 guidelines MedDRA, ectd, ESTRI, E2B, CTD, M3
23 Drug Development Strategy for Approved drugs in Japan Total.NDA Based on Bridging Strategy Based on GCTs 80 Number of approbed NDA % of applications basedon Bridging Strategy or GCTs Year
24 ICH / 1. Global Cooperation Group (GCG: 1999-) ASEAN RH ICH DRA) ICH 2. Regulators Forum ( ) ICH RHI: APEC, ASEAN, PANDRA, GCC, SADAC DRA: Australia, Brazil, China, India, Chinese Taipei, Singapore, Russia
25 Regulatory Forum GCP GCP E6) DRA GCP GCP GCP 25
26 GHTF 26
27 SG Liaison Bodies - Asian Harmonization Working Party (AHWP) -ISO (Steering Committee; SC) Ad hoc UDI (Study Group1) (Study Group2) (Study Group3) (Study Group5) IVD Subgroup 4 (Study Group4) QMS 27
28 Perspective GHTF GHTF Regional Member AHWP GHTF Pan American Health Organization (PAHO) ACCSQ-MDPWG* Latin America Harmonization Working Party(LAHWP) *ASEAN Consultative Committee for Standards and Quality - Product Working Group on Medical Device 28
29 AHWP 51 ASEAN10 (
30 2006 ICCR 30
31 PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme 31
32 PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme GMP GMP PIC/S WG 32
33 33
34 FDA EC/EMA EMA USP EU : HBD FDA
35 - EMEA FDA 35
36 36
37 37
38 (2009 GDP GDP % % ( ( ( (2009 (2009 ( % % 38
39 u u u u u u u u u 3 u
40 Clinical Data PK Data Clinical Data Clinical Data
41 2009 SFDA-MHLW
42 SFDA GLP/GCP KFDA 3 2) PMDA
43 Phase Phase 43
44 44
45 Foreign Japan Phase I Phase I 及要 ぼ因No しが( て効い) 果るにか重 影響を民族的大な Yes Phase III Phase III 45
46 Q&A 46
47 Trends of MRCTs including Japan -% of MRCTs in Clinical Trial Notifications Numbers of All CTN % of MRCTs 0 Early FY2007 (Apr-Sep) Late Early Late Early FY2007 FY2008 FY2008 FY2009 (Oct-Mar) (Apr-Sep) (Oct-Mar) (Apr-Sep) Late FY2009 (Oct-Mar) Early FY2010 (Apr-Jul) 0
48 % 12.4% 15.0% 55.8% 48
49 1. 3 East Asian Pharmaceutical Regulatory Symposium 2008 Japan-Korea-China Drug Clinical Trial Symposium 2009 Multi-Regional Clinical Trials Seoul Workshop, highlighting Korea, China and Japan Tripartite Symposium China-Japan Symposium on Global Clinical Trials and Ethnic Factors APEC2009 & 2010 Multi-Regional Clinical Trials Seoul Workshop
50 APEC LSIF (Life Science Innovation Forum) Leaders Meeting Ministerial Meeting Senior Officials Meeting Committee on Trade and Investment LSIF Source: APEC Regulatory Harmonization Steering Committee (RHSC) Regulatory Member: Canada, China, Japan, Korea, Peru, Chinese Taipei, Thailand, USA
51 APEC (
52 /PMDA MRCT MRCT MRCT APEC MRCT / MRCT 52
53 EU Japan ASIA ASEAN APEC North America USA Canada
54 Homepages, MHLW Homepage: PMDA Homepage:
制度から見る薬剤師の役割
平成 26 年 12 月 11 日第 31 回 ICH 即時報告会日本薬学会長井記念ホール Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management 医薬品医療機器総合機構 再生医療製品等審査部 岸岡康博 1 本日の内容 背景 リスボン会議での議論 今後の予定 2 経緯 ~2014
制度から見る薬剤師の役割
平成 27 年 7 月 23 日第 32 回 ICH 即時報告会全電通労働会館 ( 全電通ホール ) ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management 医薬品医療機器総合機構 再生医療製品等審査部 岸岡康博 1 本日の内容 本トピックの目的 リスボン会議後から福岡会議までの活動
PowerPoint プレゼンテーション
第 40 回 ICH 即時報告会 M2 topic : Electronic Standards for the Transfer of Regulatory Information (ESTRI) 独立行政法人医薬品医療機器総合機構 M2 EWG MHLW/PMDA Expert 新薬審査第一部佐藤大介 1 本日の内容 M2 の位置づけ 役割 アムステルダム会合の主な結果 FHIR に関する White
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Pharmaceutical Segment 12 13 14 Pharmaceutical Segment 15 16 Pharmaceutical Segment 17 GERMANY CHINA JAPAN U.S.A. KOREA SINGAPORE 18 Pharmaceutical Segment 19 20 Pharmaceutical Segment 21 22 Pharmaceutical
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おことわり 本発表は演者の個人的見解を示すものであり PMDA 及び ICH Q12 EWG の公式な見解ではないことにご留意ください 2
第 18 回医薬品品質フォーラム ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management 医薬品医療機器総合機構新薬審査第四部八木聡美 1 おことわり 本発表は演者の個人的見解を示すものであり PMDA 及び ICH Q12 EWG の公式な見解ではないことにご留意ください
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