Spring Intro 2023

06/03/2023

Regulation Governing Advanced Therapies

Directive 2001/83/EC Community code relating to medicinal products for human use Regulation (EC) No 726/2004

Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Regulation (EC) No 1394/2007

33 Essentially advanced therapies are still governed by the overarching Directive 2001/83/EC but with some amendments and additions

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Who Regulates ATMPs?

• ATMPs as defined in Article 2 of Regulation (EC) No 1394/2007 fall under the mandatory scope of the EU Centralised Procedure (Article 3(1))

• EMA is the primary review coordinating body

• Each member state has a representative and alternate on each of the EMA committees: ● CAT – Committee for Advanced Therapie s ● CHMP – Committee on Human Medicinal Products • CAT and CHMP appoint Rapporteur and Co-Rapporteur for the review of ATMPs

• European Commission (EC) Adopt CHMP Decisions

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