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...
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...
The Heads of Medicines Agencies (HMA), in collaboration with the European Medicines Agency (EMA), has released the third report on the integration of Real-World Evidence (RWE) in regulatory decision-making. From February 2024 to February 2025, the number of RWE...
On 11 March, the Commission proposed a new regulation, the Critical Medicines Act, to enhance the availability of critical medicines in the European Union (EU). This initiative complements other legislative proposals addressing medicine shortages, including the by...
On 10 April 2024 , the European Parliament has adopted its position on the EU pharmaceutical reform. The new pieces of EU law come from the "pharmaceutical package" proposed by the European Commission in April 2023 to amend EU pharmaceutical laws. This package aimed...
The Regulatory Science Network Netherlands Annual Workshop: Pharmaceutical legislation – Highway to innovation was held on 6 June in Utrecht
The European Commission has just adopted the proposal of the revision of the European pharmaceutical legislation.
The summary report on the public consultation on the revision of the general pharmaceutical legislation has been recently published.
In October 2021, the European Commission (EC) released the Good Lay Summary Practice (GLSP) Guidance
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