Tag: Vigilare BP

Pharmacovigilance Mandates and Regulations in India Key Insights about the CDSCO Framework

Pharmacovigilance Mandates and Regulations in India Key Insights about the CDSCO Framework

India’s pharmaceutical market continues to expand, and with the growth comes greater responsibility for drug safety oversight. The Central Drugs Standard Control Organization (CDSCO) plays a central role in shaping the country’s pharmacovigilance framework. Key

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Why Regulatory Affairs is Central to Drug Development?

Ideating, researching, and developing a drug or biologic product and bringing it to market is not a simple process. From preclinical discovery through market authorization, every stage of the drug lifecycle is critical. Across the

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Pharmacovigilance in 2026 – What is Expected to Change in the Regulatory Landscape Across Regions?

Why PV Mandates Matter in 2026? Pharma manufacturers are rapidly launching their products across borders, directly intensifying the burden on safety monitoring. On the other hand, to enable quick signal detection, the PV processes are

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PV Regulation (EU) 2025/1466 A Quick Note on Amendments and Compliance Checklist for MAHs

Pharmacovigilance (PV) Regulation (EU) 2025/1466 is not just an annotation to Regulation (EU) 520/2012. It is a key arrangement for MAHs to understand how seriously they should work on safety systems (design, contract, audit, and

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