What is the Regulation for Advanced Therapies in Europe?

Advanced Therapies refers to the Regulation (EC) No 1394/2007 on advanced therapy medicinal products that bring all advanced therapies (gene, cellular and tissue-based) together within a single, integrated European regulatory framework, thereby ensuring consistency across member states.

The Regulation sets out tailor-made technical requirements for these innovative therapies and establishes new standards for clinical trials in the development of advanced medicinal products. A proper legal framework for the market authorisation of these products is to stimulate increased research in this field.

The Regulation is providing one single centralized procedure, run by the European Medicines Agency (EMEA), for the whole of the European Union for assessing the safety, efficacy and quality of advanced therapies and giving them marketing authorization.

The Regulation set up a Committee for Advanced Therapies (CAT) within the EMEA to ensure the most thorough scientific evaluation possible.

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