Plan puts timeframe on improving regulatory framework for advanced medicines in EU

20 October 2017

European lawmakers are taking action to help the successful development of what are labelled advanced therapy medicinal products (ATMPs), a category of medicines referring to gene therapies, somatic cell therapies and tissue engineered products.

While the European Medicines Agency (EMA) already has a Committee for Advanced Therapies (CAT) that prepares a draft opinion before the agency’s Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion and the authorization is granted by the European Commission (EC), there is consensus that more now needs to be done to help translate scientific progress into medicinal products available to patients.

With that aim, and through consulting with other global regulators and groups, the EC's Directorate General for Health and Food Safety (DG SANTE) and the EMA published a joint action plan on Friday.

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