Regulatory

At the DIA 2024 Global Annual Meeting in San Diego, key officials from the European Medicines Agency (EMA) shed light on the various expedited approval pathways available for sponsors of innovative drugs and Advanced Therapy Medicinal Products (ATMPs). This blog post explores the insights shared by EMA officials, delves into the various expedited pathways available, […]

Pre ANDA meetings facilitate pre-submission communications with the US FDA to discuss questions related to complex products and/or complicated drug development questions. These were introduced in GDUFA II. In the GDUFA III some pre submission meetings have been redesigned to support prospective applicants in obtaining feedback from the Agency regarding their complex generics or complicated

Regulatory authorities across the globe play a pivotal role in safeguarding patient safety and ensure regulatory compliance. Each authority functions in its unique way to uphold standards and ultimately ensure the well-being of individuals. In the UK, the MHRA shoulders the vital responsibility of ensuring that medicines, medical devices, blood components for transfusion are safe, of

The US FDA conducts drug manufacturing inspections for facilities to ensure they are compliant with the Current Good Manufacturing Practice (cGMP) standards. However, navigating through these inspections requires a clear and comprehensive understanding of several aspects. These include applicable manufacturing standards, site selection model, 483 forms, and how the FDA reviews the inspections and outcomes.

Artificial Intelligence in Medicine Regulation– a perspective by Emer Cooke, Executive Director of the European Medicines Agency. Introduction Artificial Intelligence (AI) is revolutionizing the regulation of medicines by offering innovative solutions to enhance drug safety, efficacy, and overall patient well-being. With its ability to process vast amounts of data, identify patterns, and predict potential risks,

The level of scrutiny surrounding animal medicinal products has strengthened more adverse events (AEs) associated with such products have emerged in animals. Indeed, AEs and adverse drug reactions (ADRs) is a cause of concern for veterinarians. Several cases of toxicity from commonly used drugs have been reported, in canines, for example. These include licosamides that