Posted by Michael Wonder on 01 Feb 2018
Evaluation of advanced therapy medicines
1 February 2018 - Updated procedural advice clarifies regulatory process for advanced therapy medicinal products
The EMA has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, 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 of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.
It is an important step forward in the support of developers as it addresses their need for more clarity in the evaluation procedures for these innovative medicines.
