BRIEF—EMA updates on evaluation of advanced therapy medicines

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 procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorizations, 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, the Agency stated.

ATMPs are medicines for human use that are based on genes, tissues or cells.

These therapies offer ground-breaking new opportunities for the treatment of disease and injury.

They are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate.

In addition, the revized procedure gives developers more time to respond to questions raised by the committees by allowing longer clock-stops (the time period in which the company prepares answers to questions from EMA’s committees).