日米医療機器の臨床試験におけるGCP要求事項の比較

1 72 70 2010 JULY GCP HBD WG 4 RAPS Regulatory Affairs Professionals Society Regulatory Focus 2010 4 Comparing GCP Requirements for Medical Device Clinical Trials in the US and Japan HBD WG 4 Harmonization-by-Doing Working Group 4 GCP GCP GCP GCP GCP GCP GCP GCP GCP 4 HBD WG 4 WG 4 best practices 3 WG 4 GCP 4 GCP 70 2010 JULY)

2 73 GCP GCP EU ICH GCP E6 R1 1 ISO 14155 2003 2 GCP JGCP 2005 FDA 2007 1 GCP GCP GCP GCP GCP GCP GCP GCP GCP GCP 4 GCP GCP 74 70 2010 JULY GCP GCP 4 GCP GCP 12 2 2 2 ICH E6 ISO

3 GCP GCP 3 3 2 GCP FDA GCP GCP GCP GCP GCP GCP GCP GCP GCP GCP GCP GCP 70 2010 JULY)

4 75 5 4 ISO 14155 3 GCP 4 GCP GCP GCP GCP David LePay Joanne Less Jessica Greenwood Sandra Maddock Susan Dunsmore Christina Allen WG 4 Carole Carey 1 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice:Consolidated Guideline.

5 (Note:While the ICH E6 guideline is specifically applicable to drug and biological products, it has been applied as a GCP reference standard for some device studies, and has therefore been included in our analysis). 2 ISO 14155:2003. Clinical Investigation of Medical Devices for Human Subjects, Parts 1 and 2. 3 HBD Working Group 4 (Regulatory Convergence and Communication) 76 70 2010 JULY 4 5 April 26, 2007. 2009 12 16 Neal E. Fearnot, WG 4 Fearnot Cook Group Incorporated FDA HBD 70 2010 JULY) 77 1 GCP ICHGCP ICH E6 R1 : GCP ISOGCP ISO 14155:2003. 1 2 1 GCP 145 35 14 7 11 36 15 12 ) 1 36 16 7 36 17 3 23 GCP 0720005 GCP 17 7 20 17 7 20 GCP US 21 CFR 11 Electronic Records;Electronic Signatures US 21 CFR 50 Protection of Human Subjects US 21 CFR 54 Financial Disclosure by Clinical Investigators US 21 CFR 56 Institutional Review Boards US 21 CFR 812 Investigational Device Exemptions US 21 CFR 820 Good Manufacturing Practices Compliance Program Guidance Manual Institutional Review Boards CPGM Compliance Program Guidance Manual Sponsor Inspections CPGM Compliance Program Guidance Manual Investigator Inspections CPGM )2 42 USC section 1320a-7b.

6 The Anti-kickback Statute FDA Guidance for Industry:Guideline for the Monitoring of Clinical Investigations, January 1988 with minor editorial and formatting changes November 1998. FDA Guidance to Industry:Financial Disclosure by Clinical Investigators, March 20, 2001. FDA Guidance to Industry:Guidance for Institutional Review Boards and Clinical Investigators 1 ISO 14155:2003 2 CPGM 2008 12 FDA IND 21 CFR812 78 70 2010 JULY 2 1 2 3 4 5 6 7 8

7 9 10 11 1 GCP 4 2 ;FDA Guidance for Industry:Guideline for the Monitoring of Clinical Investigations, January 1988 with minor editorial and formatting changes November 1998 2 GCP 14 1 1 ;21 CFR Elements of informed consent 3 US 21 CFR FDA;Guidance for Industry: Financial Disclosure by Clinical Investigators, 20 March 2001 4 GCP 71 1 ; , , and 5 GCP 70 4 7 2 ;21 CFR , 6 GCP 2 3 11 ;21 CFR (i) 7 GCP 65 1 ;21 CFR 8 GCP 65 2 9 US 21 CFR (s), (a)(1) and (b)(1); 275 273 10 GCP 24 2 7 11 GCP 31 ;21 CFR and 70 2010 JULY) 79 3 1 2 3 4 5 6 7 8 9 10 11 12

8 1 GCP 13 1 1 3 ;CPGM Part III (B)(1)(c) 2 GCP 13 1 ;42 USC section 1320a-7b. Anti-kickback Statute 3 GCP 55 2 (GCP 2) 4 21 CFR (e) 5 GCP 74 2 3 ;21 CFR (b)(5) 6 GCP 7 7 21 CFR (b)(4) and 8 GCP 66 1 ;21 CFR (a) (4) and (a) 9 GCP 26 2 (GCP 1) 10 GCP 11 25 ;21 CFR 11 GCP 25 2 12 GCP 32 2 ;21 CRF (b)(2 and 3) 80 70 2010 JULY HBD WG 4