The EU Commission submitted its proposals for EU new pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004, including the legislation on medicines for children and for rare diseases) on 26th April, 2023. This is the largest reform in over 20 years, aiming at making medicines more available, accessible and affordable in the EU, among others.
The challenges this reform addresses are fundamental, and some of the key elements of the proposal are:
– Changes in the period of market protection for innovative, pediatric, orphan, repurposing, generic and biosimilar medicines
– Reduction of the timetables for scientific assessments, news on scientific support and simplified regulatory procedures
– New requirements for ERAs
– Measures for:
- Increasing the affordability of medicines
- Reducing antimicrobial resistance
- Future-proofing to make sure that the regulatory system can keep pace with scientific and technological progress
- Fight medicines shortages
This adopted act is open for feedback. All feedback received will be summarized by the European Commission and presented with the aim of feeding into the legislative debate.
From Asphalion, we can help you understand how this implementation may impact your company.