Life Sciences & Healthcare Newsletter: The Proposed New European Pharmaceutical Regulation

On 26 April 2023, the European Commission published a proposal for a Directive and a Regulation, which will revise and replace the existing general pharmaceutical legislation (Regulation (EC) No 726/2004 and Directive 2001/83/EC) and the legislation on medicinal products for paediatric use and rare diseases (Regulation (EC) No 1901/2006 and Regulation (EC) No 141/2000, respectively).

With this new regulation, the European Union intends to strengthen its regulatory framework in the pharmaceutical sector with the underlying idea of increased accessibility to medicines for all its citizens, but also with the perspective of innovation and supporting competitiveness.

SRS Legal addresses this and other topics in its latest newsletter Life Sciences & Healthcare.