Bacteriophages and AMR, the beginning of a new era?

The newly published EMA draft guideline on the quality aspects of phage therapy medicinal products paves the way for the use in Western Europe of this new - albeit century-old - approach to treating antibiotic-resistant infections

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

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