國際 GCP 查核制度概況 - cde.org.tw

1 RegMed 2016 Vol. 66 1 GCP 1 86 7 1 GCP GCP GCP GCP GCP GCP GCP (Routine) (For Cause) ( ) (European Union) (European Union EU) (Centralized Authorization) (National Authorization) HIV/AIDS (European Medicines Agency EMA ) EMA EMA GCP 1 RegMed 2016 Vol.

2 66 2 GCP EMA GCP GCP (United States) FDA GCP OSI Office of Scientific Investigations ORA Office of Regulatory Affairs OSI CDER Center for Drug Evaluation and Research OSI ORA GCP OSI GCP ORA OSI GCP 1 review division 2 CRFs data listings Form 1572 3 (assignment memo) ORA Districts 4 ORA Establishment Inspection Report; EIR 5 Warning Letters Untitled Letters ORA GCP 5 Regional Office 20 District Office 13 150 Resident Post Border Station PDUFA (Prescription Drug User Fee Act) (Investigational New Drug; IND) (New Drug Application; NDA) (Biologics License Application; BLA) (data audit) (Review division) (Clinical Investigator; CI) (Sponsor/Monitor; S/M) (Contract Research Organization; CRO) (Institutional Review Boards; IRB) RegMed 2016 Vol.

3 66 3 (Japan) GCP PMDA (Pharmaceuticals and Medical Devices Agency) 2004 4 1 (Ministry of Health, Labor and Welfare MHLW) GCP PMDA ( Office of Conformity Audit 2015 Office of Non-clinical and Clinical Compliance) PMDA (Ministry of Health, Labour and Welfare MHLW) PMDA (South Korea) GCP Korea Food & Drug Administration KFDA) 2013 KFDA The Ministry of Food and Drug Safety MFDS) Pharmaceutical Safety Bureau Clinical Trials Management Division 2 (Inspection Plan) 3 NDA /CRO ( ) (CFDA) ( ) ( ) CFDA 3 31 CFDA CFDA 3 RegMed 2016 Vol.

4 66 4 2015 7 22 (2015 117 ) CFDA ( ) CFDA ( ) (CRO) CFDA CRO CRO (European Union EU) 30 60 (1) (2) EU (3) (4) (5) (6) (United States US) USFDA Risk-Based Site Selection RegMed 2016 Vol.

5 66 5 Tool USFDA NDA Submission Package OSI (1) (AEs) SAEs (2) (3) / (Japan) PMDA GCP SAE PMDA GCP GCP GCP ( IRB SMO ( ) GCP ( CRO ) ( ) PMDA ( Office of New Drug) (GCP ) NDA ( ) (GCP ) NDA (NCE) 4 NDA 2 (GCP ) (South Korea) 2 1 KFDA ( MFDS) 3 RegMed 2016 Vol.)

6 66 6 Phase III study (1) (2) NCE recombinant product cell therapy gene therapy (3) (4) (5) (6) /CRO SAE/SUSARs GCP GCP GCP GCP GCP GCP 3-5 GCP (1) AEs SAEs (2) (3) GCP RegMed 2016 Vol.

7 66 7 GCP GCP CRO IRB GCP GCP USFDA black list 2015 9 1 GCP GCP EU 1. EMA 2. Procedure for coordinating GCP inspections requested by the CHMP 2014 3. Guidance on triggers for inspections of bioequivalence trials 2013 4.

8 Points to consider for assessors, inspectors and EMA inspection coordinators on the identification of triggers for the selection of applications for routine and/or for cause inspections, their investigation and scope of such inspections 2013 RegMed 2016 Vol. 66 8 USFDA 1. US FDA 2. FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL (CPGM) PROGRAM CHAPTER 48- BIORESEARCH MONITORING CLINICAL INVESTIGATORS AND SPONSOR- INVESTIGATORS 3. CDER 21st Century Review Process Desk Reference Guide (Version: September 2012) 4. Seminar on US FDA GLP Compliance Monitoring Program-US FDA OSI 5. CDER Forum for International Drug Regulatory Authorities: CDER Office of Scientific Investigations: Introduction and Overview-US FDA OSI 6. Bioresearch Monitoring and Inspections-US FDA OSI 7. CDER's Role in FDA's Bioresearch Monitoring Program and Human Subject Protection-US FDA OSI 8.

9 DSI and Bioresearch Monitoring (BIMO)-US FDA OSI 9. Final FY2012_OSI Metrics_vJan2013-1-24-13-DIA Japan 1. PMDA 2. GCP 2006 3. GCP , 2011 4. 2011 5. PMDA GCP - PMDA 2012 6. GCP -PMDA 2014 RegMed 2016 Vol. 66 9 Korea 1. MFDS 2. 2015 (2015 Clinical Trial Inspection Plan ) 3. 2014 APEC LSIF Joint Multi-Reginal clinical trials and Good Clinical Practice Inspection Workshop -GCP Inspection in Korea 2014 China 1. CFDA 2. 2014 3. 2015 4. 2015 5. 2015 6. 2015