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Requirement of clinical trials on Indian populations The requirement for clinical trials o...

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Phase IV trials Phase IV trials in vulnerable and special groups, e.g. pregnant women, chi...

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All NCEs/NMEs undergoing clinical trials anywhere can also undergo paralJel Phase II and P...

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Observational studies Observations on AEs, SAEs and benefits seen by the clinician or heal...

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SIXTH SCHEDULE (See rules 21, 22, 33, 34, 45, 47, 52, 53, 60, 67, 68, 75, 76, 80, 81, 86, ...

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First-time genencs manufactured in India will undergo bridging Phase III trials and bioequ...

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Thereafter, the Committee will approve the protocol, investigators and centres for the con...

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Technical Review Committee Background Interaction with the pharmaceutical industry leaders...

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Terms of reference 1. To formulate policy, guidelines and standard operating procedures (S...

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