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Important The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a first-of-its-kind regulatory sandbox designed to explore how artificial intelligence (AI) can support safer medicines…
Important U.S. Food and Drug Administration issued a final guidance for industry titled Postapproval Pregnancy Safety Studies on May 8, 2026. The guidance provides recommendations on methodologies that can…
The post-approval phase of a medicinal product’s lifecycle represents a critical period for continuous safety monitoring. As medicines are exposed to larger and more diverse patient populations, new…
The increasing availability of biosimilar medicinal products has transformed healthcare by expanding patient access to life-saving biological therapies while reducing treatment costs. Biosimilars are highly similar to an…
In the evolving landscape of pharmacovigilance, signal management has become a central pillar in ensuring drug safety and maintaining compliance with global regulatory affairs requirements. It goes beyond…
Ensuring business continuity in pharmacovigilance operations is essential for safeguarding public health by continuously monitoring the safety of medicinal products. Any disruption in PV operations—whether due to system…
Important The U.S. Food and Drug Administration announced on March 11, 2026, the launch of a new unified platform for analyzing adverse event reports. The system, known as the…
Drug safety, is a critical component of the healthcare and pharmaceutical industries. It focuses on detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. As…
Under the EU Good Pharmacovigilance Practices (GVP), Marketing Authorization Holders (MAHs) are required to maintain a fully functioning, compliant, and continuously monitored Pharmacovigilance (PV) system. To achieve this,…
Important China’s (NMPA) has announced enhanced regulatory measures following the formal revision of the Implementing Regulations of the Drug Administration Law. The updated rules were promulgated through a State…
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