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ATMP registration

ATMP registration

Besides the EMA guide on Advanced Therapy Medicinal Product (ATMP) development the EMA also has a streamlined procedure to gain Marketing Authorization (MA) for an ATMP.

The Committee for Advanced Therapies (CAT) has a large role in this procedure; starting from ATMP classification assessment to Marketing Authorization. The CAT is involved in orphan designation, PRIME and ATMP accelerated assessment requests. They have the key responsibility for the MA evaluation of an ATMP on quality, safety and efficacy. Nevertheless, there is a close collaboration with the Committee for Medicinal Products for Human Use (CHMP). The CHMP is informed during its plenary meeting of the major objections and key scientific issues raised during the evaluation of the ATMP. Finally, the CAT provides the draft opinion to the CHMP, in many cases the CHMP adopts their opinion. Hereafter the MA procedure is similar as for regular medicinal products.

Due to the use of new/state-of-the-art technologies developers of ATMPs may need longer periods to respond to questions. On justified grounds, the CAT may agree to a longer clock-stop during the evaluation.

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ATMP registration