On 8 November, the BioMed Alliance submitted its public reply to the Consultation on the Revision of the EU general pharmaceuticals legislation. The Commission proposal which entails a substantial review of the EU legislative framework for pharmaceuticals, includes provisions on e.a. general pharmaceuticals, orphan medicinal products, paediatric medicines and the EMA.
The Alliance welcomed the proposals and the intention to address persisting challenges including medicine shortages, their affordability and antimicrobial resistance in its reply, but stressed that certain aspects still need to be refined or further clarified. The reply mainly focused on the need to: support research and innovation, create balanced and effective incentives, draft a fit-for-purpose definition of Unmet Medical Needs, support repurposing and to better support the development, evaluation and approval of paediatric medicines.