The document provides an overview of clinical trial regulations in India, China, and Russia. It discusses key aspects of India's regulatory history and framework, including important definitions, the roles of regulatory agencies like CDSCO and DCGI, clinical trial application requirements, and current applicable regulations like Schedule Y and GCP guidelines. It also briefly outlines the agenda for a discussion on practical experiences with QA audits in these countries.

2. Overview of Clinical Trial Regulations in India, China and Russia

3. India

4. A Brief History of Regulating Medicinal Products in India 1940 Drug and Cosmetics Act (British India) 1970 Indian Patents Act (Only Recognizing Process Patents and Not Composition of Material) 1945 Drug and Cosmetics Rule India gains Independence from Britain in 1947 1988 Schedule Y Requirements & guidelines for permission to import and/or manufacture new drugs for sale or to undertake clinical trials in India 2000 ICMR issues “Ethical Guidelines for Biomedical Research on Human Subjects” 2002 ICMR issues “Good Clinical Practices for Clinical Research in India” Indian government allowed for 100% direct foreign ownership of Pharmaceutical companies

19. CDSCO Central Government Directorate General of Health Services Drugs Controller General of India Permissions for Clinical Trials with New Drugs Test Import Licenses New Drug Approvals Ministry of Health & Family Welfare

22. DCGI Permission Drugs Manufactured In India Permission to Conduct Clinical Trials Drugs Manufactured Outside India Test Import License Permission to Conduct Clinical Trials + DGFT Approval for export of samples As we speak, this is no longer a requirement!

28. China

29. Brief History of Regulations - China Ministry of Health Administration Guidance for Drug Manufacturing 1982 Ministry of Health Administration Guidance for New Drug 1979 State Council Provisional Guideline for Drug Administration 1978 Ministry of Health Provisional Administration of New Drugs 1962 Conception (1962-1982) Issued By Regulations / Laws Year Stage

30. Brief History of Regulations - China SDA Quality Control Guideline for Drug Clinical Trials 1999 SDA Guidance for New Drug Evaluation and Approval (revised) 1999 State Council Establishment of SDA 1998 Ministry of Health Administration Guidance for Clinical Trials of New Drug 1997 Ministry of Health Guidance for New Drug Evaluation and Approval 1985 State Council Regulations for Implementation of Drug Administration of Law of the People’s Republic of China 1985 National People’s Congress Drug Administration of Law of the People’s Republic of China 1984 Development (1984-1999) Issued By Regulations / Laws Year Stage

31. Brief History of Regulations - China SFDA Quality Control Guideline for Drug Clinical Trials (Revised) 2003 State Council Establishment of SFDA 2003 SDA Provisions for Drug Registration (Draft) 2002 State Council Regulations for Implementation of Drug Administration of Law of the People’s Republic of China 2002 National People’s Congress Drug Administration of Law of the People’s Republic of China (Revised) 2001 SFDA Provisions for Drug Registration 2005 National People’s Congress Administrative Permission 2004 Maturation (2001-2005) Issued By Regulations / Laws Year Stage

34. Regulatory Framework in China State Food and Drug Administration (SFDA) State Ministry of Health Issued Provisions for Drug Registration (SFDA Order No.28)

47. Russia

60. GCP Overview (India, China and Russia)

78. Differences with ICH E6 Let’s Talk

81. Practical Experiences with QA Audits in India