Reform of the EU pharmaceutical legislation
The Commission just adopted a proposal for a new Directive and a new Regulation, which revise and replace the existing general pharmaceutical legislation.
The proposal adopted by the Commission revises and replaces the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively).
The revision aims to achieve the following main objectives:
- Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines
- Enhance the security of supply and ensure medicines are available to patients, regardless of where they live in the EU
- Continue to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe
- Make medicines more environmentally sustainable
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach.
OpenEdition vous propose de citer ce billet de la manière suivante :
abottacci (27 avril 2023). Reform of the EU pharmaceutical legislation. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/o694
