European Commission

Many advancements in the setting up of the new pharmaceutical legislation

On 11 December 2025, the Trilogue reached an agreement on the final text of the “pharma package”, which includes the regulations and directives governing the development, production and commercialisation of medicinal products in the EU. The package now awaits formal adoption by the European Council and Parliament before it can enter into force. We summarise the main features of the reform of the European pharmaceutical legislation

The EU Commission adopted the rules for JCAs of medical devices and in vitro diagnostics

The last of the six implementing regulations concerning HTA procedures was published on 17 October 2025. It describes the detailed procedures to perform the joint clinical assessment of medical devices and in vitro diagnostics

The challenging roadmap to design the future of EU’s R&D

The ongoing debate on simplifying and standardising the rules for accessing EU research funding is in an hot phase. ERC president Maria Leptin rejected the Commission’s proposals, while the ERC Scientific Council published its new rules for the evaluation of scientific proposals. In a recent speech on the advancement of the Competitiveness Compass, Mario Draghi emphasised the need for a more proactive approach to priority programmes on critical technologies. He also drew attention to dual-use technologies, an approach combining civil and defence applications which has divided the EU Parliament

Consultation open on the revision of GMP’s Chapter 1

Comments on the draft revision of Chapter 1 of the Good Manufacturing Practices must be submitted by 3 December 2025. The revision aims to update this fundamental text in light of the more recent advancements in pharmaceutical manufacturing, so to better ensure the ef-fectiveness and safety of medicinal products. The EIPG will liaise with member associations to submit a joint response to the draft text.

Pharmaceuticals in the environment, the final report of the Ad Hoc Working Group

The final report of the Ad Hoc Working Group on Pharmaceuticals in the Environment sets out the recommendations to be considered during the revision of the pharmaceutical legislation, covering seven different aspects relevant to the optimal management of medicine residues and waste

Latest EMA’s updates on the use of RWE in regulatory decision-making

The third annual report on the integration of real-world evidence (RWE) into regulatory decision-making shows a marked increase in the number of RWE studies conducted by the three pathways for generating RWE, the European consortium DARWIN EU, the framework contract (FWC), and in-house EMA studies. The PRAC Committee gave rise to the higher number of requests in the monitored period