Regulatory affairs has never exactly been a slow moving field. But 2026 feels different. Agencies that spent years cautiously watching AI from a distance are now actively deploying it. Real world evidence once a nice
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Given the abundance of connected devices, cloud-linked systems, software-driven platforms, and their ability to pose direct risks to patient safety, data integrity, and product reliability, Cybersecurity has now become more than a compliance issue. From
Read MoreIndia’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
Read MoreIndia’s pharmaceutical sector is evolving from high-volume output to strategic global importance. The domestic market, currently USD 50–60 billion, is projected to reach USD 130 billion by 2030. With FY2026 growth forecasts of 7%–11%, India
Read MoreGlobally, Pharmacovigilance (PV) is built on one central idea: the benefit–risk evaluation should not stop at approval; it must continue through the full drug development regulatory process and the product’s commercial lifecycle. It is no
Read MoreIn Europe, Pharmacovigilance is heavily dependent on submitted documents. Each core submission enables regulators to assess how data has been maintained throughout the product life cycle. This approach minimizes risks. A robust safety system can
Read MoreDespite being an established practice in the pharmaceutical industry, the question ‘What is Pharmacovigilance?’ remains a frequently asked one among the general public, students, and healthcare professionals, including doctors and nurses, in developing regions.  Whether
Read MoreStepping into 2026, the challenge for marketing authorization holders (MAHs) is not only to address AI intrusion into pharmacovigilance but also to ensure their existing pharmacovigilance systems are compliant, all-through, controlled, data-driven, and inspection-ready for
Read MoreThe European Medicines Agency (EMA) is re-examining its approach to drug safety. The 2026 pharmacovigilance (PV) framework marks significant progress in using real-world evidence (RWE) to monitor medicines and inform regulatory decisions in the European
Read MoreWhy 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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