EMA: Reflection paper on classification of advanced therapy medicinal products

In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015, repealing Directive 2001/20/EC following a transition period lasting through 28 May 2016. Further to the implementation of Article 17 of Regulation (EC) No 1394/2007i (hereinafter referred as to ‘the Advanced Therapy Medicinal Products (ATMPs) Regulation’), applicants have access to an optional procedure which is the CAT (Committee for Advanced Therapies) scientific recommendation for the classification of ATMPs, hereafter referred to as “ATMP classification”. It is underpinned by the ATMP Regulation which enables the European Medicines Agency (EMA) in close collaboration with the European Commission to determine whether or not a given product meets the scientific criteria, which define ATMPsii. The ATMP classification procedure has been established in order to address, as early as possible, questions of borderline cases where classification of a product based on genes, cells or tissues is not clear. The CAT issues scientific recommendations determining whether or not the referred product falls, within the definition of an ATMP in the European Union.