Regulatory Blog

As pharmacovigilance systems continue to move toward standardized electronic reporting, efficient and reliable exchange of Individual Case Safety Reports (ICSRs) is essential for the timely management of adverse drug reaction information. Swissmedic has established an electronic exchange process based on the ICH E2B(R3) standard for the transmission of ICSRs between Marketing Authorisation Holders (MAHs) and Swissmedic. The Guidance for Industry on the Electronic Exchange of

Regulatory submissions for medicines and other human health products involve a range of application, assessment, maintenance, inspection, and administrative fees. The Health Products Regulatory Authority (HPRA) Guide to Fees for Human Products provides applicants with a structured framework for identifying the appropriate fee category and fee code to accompany applications submitted to the Authority. The guide covers fees associated with medicines, clinical trial authorisatio

Ensuring the availability and continuity of medicines across the European Union is an important priority for the European Medicines Regulatory Network. Supply chain disruptions can affect medicine availability, making it important for Marketing Authorisation Holders (MAHs) to identify potential risks and establish appropriate measures to reduce the likelihood of shortages. The European Medicines Agency (EMA) has published the Guidance for industry on implementing Shortage Pre

Clinical investigations of medical devices require a comprehensive submission that provides the MHRA with sufficient information to assess the safety and performance of the device. The MHRA guidance Clinical Investigations: Compiling a Submission explains how manufacturers should notify the MHRA of a planned clinical investigation and sets out the information and supporting documentation required for assessment. Why This Guidance Is Important The guidance provides manufacture

As medical devices become increasingly sophisticated, ensuring that they are safe and intuitive to use is just as important as demonstrating their technical performance. Many device-related incidents are not caused by product failure but by use errors that arise from complex interfaces, confusing instructions, or challenging use environments. The U.S. Food and Drug Administration (FDA) has updated the guidance Applying Human Factors and Usability Engineering to Medical Device