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Pharmacovigilance Guidelines for Marketing Authorization Holders in India

CDSCO,India has released the draft guidance document that focuses on Pharmacovigilance activities for the Marketing Authorization Holders (MAHs) in India. The intent is to create a nation-wide system for patient safety reporting, identify and analyze risks associated with use of medicinal products, analyze the benefit - risk ratio of marketed medications, generate evidence based information on safety of medicines, support regulatory agencies in the decision-making process on use of medications and communicate the safety information on use of medicines to various stakeholders to minimize the risk. For more details please click here

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