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(10 ) 900 800 200 20% 7732 ) 700 600 500 400 300 55.9 26.2 81.5 20 29 30.1 64.7 66.1 31.4 88.4 19.4 31.1 32 67.7 73.5 36.3 95.6 20.5 32.1 33.2 63.7 101.9 89.1 49.1 42.8 129.7 112.9 22.3 23.4 41.3 36.8 38.5 42.2 65.7 77 200 100 252.5 267.7 291.7 305.5 309.7 0 2004 2005 2006 2007 2008 IMS World Review 2009 3

10 1996 2008 2008 19.6 18.2 19.5 10 30.7 31.5 30.4 40.1 2,910 IMS World Review 7,732

EU5 20.3% Source: IMS Health, IMS MIDAS, MAT Dec 2006 18 5

3 2.8 4.9 2.3 0.0 2.0 4.0 6.0 8.0 10.0 12.0 7.7 4 7.2 3 2008 20 1 5 6

20 2.5 2 2009 12 7

FDA 10

100 90 80 70 60 50 40 30 20 10 0 8 17 32 48

2.5

2020 50 284 15

2010 2011 2013 2020 5 5 750 12 14

PMDA 17

2009 Office of International Programs PMDA upmda u u u 19

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

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

Drug Development Strategy for Approved drugs in Japan Total.NDA Based on Bridging Strategy Based on GCTs 80 Number of approbed NDA 70 60 50 40 30 20 10 0 40 20 0 % of applications basedon Bridging Strategy or GCTs Year

ICH / 1. Global Cooperation Group (GCG: 1999-) ASEAN RH ICH DRA) ICH 2. Regulators Forum (2008. 6 - ) ICH RHI: APEC, ASEAN, PANDRA, GCC, SADAC DRA: Australia, Brazil, China, India, Chinese Taipei, Singapore, Russia

Regulatory Forum GCP GCP E6) DRA GCP GCP GCP 25

GHTF http://www.ghtf.org/ 26

SG Liaison Bodies - Asian Harmonization Working Party (AHWP) -ISO (Steering Committee; SC) Ad hoc UDI 1 2 3 5 (Study Group1) (Study Group2) (Study Group3) (Study Group5) IVD Subgroup 4 (Study Group4) QMS 27

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

AHWP 51 ASEAN10 ( 2010 2010 2010 11 2011 29

2006 ICCR 30

PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme 31

PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme GMP GMP PIC/S WG 32

FDA EC/EMA EMA USP EU 2009 2010: HBD FDA 2010 34

- EMEA FDA 35

(2009 GDP GDP 5 17074 0.2% 13 3 3735 9.1% (2009 10 4 (2001 1032 (2009 5 8 2587 7.4 (2009 (2009 (2009 6 3941-2.3% 2 3 2329 4.5% 38

u u u u 2007 2008 4 2009 12 2010 9 2011 u u u u u 3 u

Clinical Data PK Data Clinical Data Clinical Data

2009 SFDA-MHLW 2010 5 28 2010 7 30 1 41

2010 5 7 SFDA GLP/GCP 1 11 12 KFDA 3 2) 2010 11 2912 3 PMDA

Phase Phase 43

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

19 0928010 Q&A 46

Trends of MRCTs including Japan -% of MRCTs in Clinical Trial Notifications- 300 25 Numbers of All CTN 250 200 150 100 50 20 15 10 5 % 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

21 113 16.8% 12.4% 15.0% 55.8% 48

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 2010 2. China-Japan Symposium on Global Clinical Trials and Ethnic Factors 2010 3. APEC2009 & 2010 Multi-Regional Clinical Trials Seoul Workshop

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

APEC (2010 9 13-15 51

/PMDA MRCT MRCT MRCT APEC MRCT / MRCT 52

EU Japan ASIA ASEAN APEC North America USA Canada

Homepages, MHLW Homepage: http://www.mhlw.go.jp/english/index.html PMDA Homepage: http://www.pmda.go.jp/english/index.html