Clinical Trial Application (CTA) submission in India

A Clinical Trial Application (CTA) is submitted to regulatory authority (Drugs Controller General of India) to seek approval for conduct of a clinical trial in India. Form 44 is an application made for grant of permission to import or manufacture a new drug or to undertake Clinical Trial. The trial sponsor has to submit the application (Form 44) and documents pertaining to chemical and pharmaceutical information, animal pharmacology, toxicology data and clinical pharmacology data.  Other trial-related...

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