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Evaluation of advanced therapy medicines

Evaluation of advanced therapy medicines
February 12, 2018 SueCarr

The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedures, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers navigate the regulatory process in the EU. This often applies to small and medium sized enterprises (SMEs) or academic spin-offs.