Many advancements in the setting up of the new pharmaceutical legislation

On 11 December 2025, the Trilogue reached an agreement on the final text of the “pharma package”, which includes the regulations and directives governing the development, production and commercialisation of medicinal products in the EU. The package now awaits formal adoption by the European Council and Parliament before it can enter into force. We summarise the main features of the reform of the European pharmaceutical legislation

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