Clinical Trial Approval Process in India, with Fees and Timelines
The clinical trial approval process in India involves submitting an application to the Central Drugs Standard Control Organization (CDSCO) and obtaining ethics committee approval. The CDSCO reviews the scientific and technical aspects of the trial, while the ethics committee ensures participant rights and safety. Required documents include the investigator's brochure, study protocol, informed consent forms, and safety data. The process includes application submission, review, and potential request for additional information. Once approved, import and manufacturing licenses are obtained
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