Updates on the new EU pharmaceutical legislation
News
A space dedicated to the latest updates and developments in the reform of European pharmaceutical legislation.
Feedback period on the Biotech Act is now open
The European Commission has opened a feedback period on the forthcoming European Biotech Act, allowing all stakeholders to express their views in the legislative debate. The European Biotech Act Ion establishing a framework of measures for strengthening Union’s...
Published the texts of the Regulation and the Directive as deriving from the trilogues negotiations
The texts of the forthcoming European Pharmaceutical Package, including a Directive and a Regulation[1], as agreed during the interinstitutional negotiations concluded in December 2025, have been made publicly available on 6 March. These texts also received positive...
Updates on the new EU pharmaceutical legislation
On 11 December 2025, a landmark political agreement was reached by the European Commission (EC), the European Parliament and the Council of the European Union on the comprehensive reform of the EU pharmaceutical legislation. The reform was first proposed by the...