European Regulatory Regimes for Regenerative Medicine (RegMed)
Regulations for development, production and approval of medicinal products are largely harmonized within the EU. The European Medicines Agency (EMA), founded 1995, is responsible for evaluation and monitoring of medicinal products in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the EMA delivers after evaluation the opinion to the European Commission for final approval.
The legal bases are mainly two fundamental instruments: Regulations and Directives. EC-Directives have to be transposed into national law of each Member State (MS), whereas EU-Regulations are directly valid for all EU-member states. Furthermore there are technical directives, guidelines and others.
At the end of December 2008, the EC-Regulation 1394/2007/EG (ATMP-Regulation) for cell and tissue based therapies came into effect, which regulates the Advanced Therapy Medicinal Products (ATMP). These include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products, as well as “combined Advanced Therapy Medicinal Product” which contain medicinal products or medical devices as components.
To meet the specifics of the ATMPs the ATMP-Regulation has several elements: it amends other aspects of European medicines law, contains provisions and rules and claims for new supporting activities and incentives by the MS-authorities and tasks the European Commission and the EMA with specific implementation steps.
The EU-Commission and the EMA are currently working on the realisation of these requirements. Explanations of the implementation concept as well as the status quo can be found on the website of the EMA.
Market Authorisation (MA)
According to the new regulation ATMPs need to obtain MA from the European Commission. They have to be generally evaluated within the scope of the central European procedure by the European Medicines Agency. Beside the Committee for Medicinal Products for Human Use (CHMP) a new specific and multidisciplinary expert committee ( Committee for Advanced Therapies, CAT) has been established for the evaluation of ATMPs. The approval by the EU-Commission permits market access in the entire EU.
The scope of the ATMP-Regulation is limited to products which are intended to be placed on the market in MS and which are either prepared industrially or manufactured by a method involving an industrial process. If an ATMP is not prepared industrially or manufactured by a method involving an industrial process, and not intended to be placed on the market in the Member State it is out of the scope of the ATMP-Regulation. For these ATMPs applies Art. 28(2) of the ATMP-Regulation, the so-called ‘Hospital Exemption’. Member States are requested to lay down rules for authorising these products by the national Competent Authority whilst at the same time ensuring that relevant Community rules related to quality and safety are not undermined.
Furthermore, the regulation of products made of living cells and tissues which do not comply with the definition of an ATMP (according to ATMP-Regulation) is also subject to national legislation of the member states.
For ATMPs which were “legally on the market” in accordance with national or community legislation on 30 December 2008 a transitional period is granted:
3 years for SCT and GT (until 30 December 2011) and
4 years for TEPs (30 December 2012).
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