Transcription of CDSCO - Guidance for Industry
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CDSCO - Guidance for Industry
Guidance for Industry Submission of Clinical Trial Application for Evaluating Safety and Efficacy Requirements for permission of New Drugs Approval Post approval changes in biological products: Quality safety and Efficacy Documents Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products Central Drugs Standard Control Organization Ministry of Health | Govt. of India Guidance for Industry Central Drugs Standard Control Organization Page 2. Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy (General considerations for conducting Clinical Trial as per Drugs and Cosmetics Act 1940 and Rules 1945). Document No. - CT/71108. Version Guidance for Industry Central Drugs Standard Control Organization Page 3. OBJECTIVE. This Guidance has been developed in conformity with Drugs and Cosmetics and Rules there under and GCP Guidelines of India for the purpose of submission of Clinical Trial application.
Guidance for Industry Central Drugs Standard Control Organization Page 3 OBJECTIVE This Guidance has been developed in conformity with Drugs and Cosmetics
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