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

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

The new Annex 21 to GMPs

by Giuliana Miglierini The new Annex 21 to GMPs (C(2022) 843 final) that EIPG gave a significant contribution…