Module 9 2021

The ATMPs regulation (1394/2007 EC)

TEPs and Combined products as a new class of ATMPs ● Bridges the gap between the 2001/83EC and 93/42 EEC Endpoints ● Comprehensive regulatory framework applicable to all Member States ● Overall legal certainty, but sufficient technical flexibility ● Market access harmonization and free movements of products within EU ● Patient protection and high level of scientific evaluation across the E.U. Committee for Advanced Therapies (CAT) at EMA ● Classification of ATMPs ● Certification of quality and non-quality data ● MA review and assessment

Novartis Pharma AG- Business use only- not for further distribution

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