EU proposes ambitious reform of pharmaceutical legislation to improve patient access, promote innovation, and tackle environmental and antimicrobial challenges.

The EU is proposing a major revision of its pharmaceutical legislation with several objectives. These include creating a single market for medicines to provide timely and equitable access to safe, effective, and affordable medicines across the EU, enhancing availability and ensuring medicines can be supplied to patients regardless of where they live, reducing the administrative burden by speeding up procedures, promoting innovation, and making medicines more environmentally sustainable. The revision includes two legislative proposals, a new Directive and a new Regulation, which simplify and replace the previous pharmaceuticals legislation. The reform also includes a Council Recommendation on antimicrobial resistance (AMR) and is the first major review of the pharmaceutical legislation since 2004. The reform aims to adapt the legislation to the needs of the 21st century.