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

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