ema

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 new European Shortages Monitoring Platform becomes mandatory

The second version of the European Shortages Monitoring Platform, to be launched on 2 February 2025, will include all functionalities to report shortage issues on a routine basis or concerning preparedness exercises or declaration of a health crisis. All the guidance needed to manage the reporting, as well as the drafting of the Shortage Prevention Plans and Shortage Mitigation Plans, is available on the EMA website

EMA guideline on investigational ATMPs

The first revision of the ERA guideline on environmental risk assessment

Consultation on the revision of the Guideline on the chemistry of active substances

Accelerating Clinical Trials in the European Union (ACT-EU)

EIPG Meeting in Rome in April