June 4, 2025
Improving the Paediatric Framework: Aligning Ambition with Reality in the Revision of the General Pharmaceutical Legislation As part of the broader revision of the EU’s General Pharmaceutical Legislation (GPL), the integration and update of the Paediatric Regulation is a timely… read more
May 27, 2025
In this guest blog post, Sarah Khor, Director, International Government Affairs & Policy at Amgen (EUCOPE member) sets out why the recently adopted WHA Resolution on rare diseases is an opportunity not to be missed for Europe. The adoption of… read more
February 27, 2025
Building on a previous blog on the need to reduce medicine approval timelines, it is imperative that all Orphan Medicinal Products (OMPs) be eligible for consideration under the EMA’s Priority Medicines (PRIME) scheme as part of the Revised General Pharmaceutical… read more
January 30, 2025
Discussions on the Revision of the General Pharmaceutical Legislation (GPL) primarily focus on the incentive frameworks, which are important contributors to innovation. Crucially, the GPL also governs a host of other elements related to drug discovery, regulation and approval which… read more
September 9, 2024
In this guest blog post, Nicholas Cosenza, Head EU Government Affairs at Amgen (EUCOPE member) discuss the importance for the European Union to maintain its biotech sector competitive on the global stage. He also provides leads on the multiple shapes this… read more