Snapshot

The EMA Advanced Therapy Medicinal Products pathway has been developed by the European Medicines Agency of EU-EMA.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: EU-EMA

277 days. *The principles for the accelerated assessment procedure in accordance with Article 14(9) of Regulation (EC) 726/2004 also apply for ATMPs as per the “guideline on the Procedure for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004”. In case of Advanced Therapy Medicinal Product (ATMP)s, the Committee for Advanced Therapies (CAT) decides on the accelerated assessment request. The timetable will be arranged to include the review by the Committee for Advanced Therapies. The initial assessment phase will last 120 days similarly to the standard marketing authorization procedure; the second phase of assessment will last 30 days - the timetable therefore is 120 + 30 days.