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

EIPG Training Course: Annex 1

Dear colleagues, I am very pleased to announce the GMP/Annex 1 Professional Training Course which will be held…