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

EU Life Sciences Strategy, comments to the call for evidence

The call for evidence closed on 17 April, and the proposal of the draft EU Life Sciences Strategy is expected by Q2 2025. It should encompass all the different industrial sectors in which life sciences play a central role for R&D and competitiveness, including pharmaceuticals, biotech and medtech

Current status and perspectives in Joint Clinical Assessment

While the first two joint clinical assessments were launched in April 2025, a document published by the European Medicines Agency and the Heads of HTA Agencies Group addresses the remaining issues to reduce uncertainty in the parallel joint assessment of the first categories of medicines and medical devices covered by the HTA Regulation

New Approach Methodologies, the EMA’s horizon scanning report

The Horizon scanning report published by the European Medicines Agency and the Heads of Medicines Agencies discusses the challenges and opportunities for the development and implementation of New Approach Methodologies (NAMs) to support regulatory decision-making

EMA guideline on investigational ATMPs

The guideline adopted by EMA’s CHMP Committee on 20 January 2025 will come into force on 1 July. It discusses in detail all the different aspects to be considered during the development of an investigational advanced therapy medicinal product, both in exploratory and confirmatory studies, in order to prepare a submission dossier adequate to support application for marketing authorisation

The proposal of a Critical Medicines Act

The Critical Medicines Act proposed by the European Commission aims to overcome supply issues and shortages of medicinal products by mean of the activation of Strategic Projects, new procurement requirements and improved international partnerships