India Profile Updated in ClinRegs
March 26, 2021
The India profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates include:
- Expanded information on the terms of reference the Central Drugs Standard Control Organization (CDSCO) uses to constitute Subject Expert Committees which advise the Drugs Controller General of India (DCGI) on new drug and clinical trial application approvals (See Regulatory Authority and Scope of Assessment)
- Additional FAQs issued by CDSCO to facilitate the clinical trial application submission process (See Scope of Assessment and Manufacturing & Import)
- Updated Serious Adverse Event (SAE) electronic reporting requirements via the SUGAM Portal (See Safety Reporting)
- New information on data protection requirements (See Definition of Sponsor, Quality, Data & Records Management, Documentation Requirements, and Participant Rights)