2/11/2025 3:50:42 PM Medical Devices in the UK: Changes to Post-Market Surveillance By Sophie Vo Quinn Liang On 11 December 2024, the MHRA published an updated roadmap for the future of the regulatory framework for medical devices in the UK,...
1/22/2025 11:28:54 AM EMA’s finalised reflection paper on the use of AI By Hester Borgers Maud van Haaren On 9 September 2024 the European Medicines Agency (“EMA”) issued its final reflection paper on the use of AI in the medicinal product...
1/13/2025 11:15:48 AM EMA and HMA Update Guidance on Commercially Confidential Information in Marketing Authorisation Applications By Benedicte Mourisse Marc Martens The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...
12/16/2024 1:59:46 PM Australian Extensions of Patent Term continue for "mixture" formulations By Jane Owen The Federal Court of Australia has confirmed that an extension of patent term for Novo Nordisk's patent claiming liraglutide plus...
10/14/2024 9:22:12 AM Fight against medicine shortages: the French Medicines Agency (ANSM) imposes fines totalling €8 million By Caroline Arrighi-Savoie Johanna Harelimana Nahla Ghouali On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...