Giuliana Miglierini

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 UK’s new decentralised manufacturing framework

The new Decentralised Manufacturing Framework came into force on 23 July 2025. It enables the production of innovative medicines products such as cellular therapies close to the patients who will receive them. The framework covers both Point of Care manufacturing and Modular Manufacturing, and it requires prior authorisation and provides an alternative to traditional, centralised productions

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

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