SOP for the Adverse Drug Reaction Advisory Committee (ADRAC) on Adverse Drug Event Reporting

The purpose of this SOP is to describe the procedures and activities of ADRAC in the review and evaluation of ADE reports received by ADRMC. It is applicable to all ADE reports received for medicinal products, including Unani, Ayurvedic, herbal, homeopathic and biochemical systems of drugs, vaccines, and biological products.

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