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.

The EU Commission’s Study on the deployment of AI in healthcare

The DG Santé published in August 2025 a very detailed study on issues to be solved to ensure the swift implementation of artificial intelligence in healthcare. The study provides a thorough analyses of the current deployment of AI systems from technical, clinical, regulatory and societal perspectives, offering suggestions on how to address open issues

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

Steps towards the new Pharma package and the EU Startup and Scaleup Strategy

In recent weeks, important steps have been taken towards the final adoption of the new European General Pharmaceutical Legislation, with the adoption of the Council’s position preliminar to the Trilogue discussions. The Commission also presented its new strategy to support European startups and scaleups, which are fundamental to improving innovation and European competitiveness