| Author (Corporate) | European Commission |
|---|---|
| Series Title | COM |
| Series Details | (2014) 188 final (28.03.14) |
| Publication Date | 28/03/2014 |
| Content Type | Policy-making, Report |
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Scientific progress has brought about a new type of medicinal products based on gene therapy, somatic-cell therapy or tissue engineering. To provide for a common framework for the marketing of so-called advanced therapy medicinal products (hereinafter "ATMPs"), Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products (hereinafter "ATMP Regulation") was adopted in 2007. The ATMP Regulation was designed to ensure a high level of human health protection as well as the free movement of ATMPs in the EU. The cornerstone of the Regulation is that a marketing authorisation must be obtained prior to the marketing of ATMPs. In turn, the marketing authorisation can only be granted if, after a scientific assessment of the quality, efficacy and safety profile, it is demonstrated that the benefits outweigh the risks. The application for a marketing authorisation must be submitted to the European Medicines Agency (hereinafter "Agency") and the final decision is taken by the Commission. This procedure ensures that these products are assessed by a specialised body (the Committee for Advanced Therapies; hereinafter "CAT") and that the marketing authorisation is valid in all the EU Member States. The ATMP Regulation empowered the Agency to make scientific recommendations as to whether a given product should be considered an ATMP (hereinafter "classifications"). Additionally, it provided for a new instrument, the so-called certification procedure, designed as an incentive for small and medium sized enterprises (hereinafter "SMEs") that were involved in the first stages of the development of ATMPs but lacked the resources to conduct clinical trials. Specifically, the certification that the quality and preclinical aspects of the development are in conformity with the relevant regulatory requirements was expected to help SMEs attract capital and to facilitate the transfer of research activities to entities with the capacity to market medicinal products. The ATMP Regulation applies since 30 December 2008. However, a transitional period was foreseen for ATMPs that were already in the EU market when the Regulation was adopted. Specifically, gene therapy and somatic cell therapy were required to comply with the Regulation by 30 December 2011, while tissue-engineered products were required to comply with the new requirements by 30 December 2012. By means of this Report, prepared in compliance with Article 25 of the ATMP Regulation, the Commission takes stock of the situation of ATMPs in the EU and analyses the impact of the Regulation on advanced therapies. The report takes account of the outcome of the public consultation on the application of the ATMP Regulation conducted by the Commission services. |
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| Source Link | http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2014:188:FIN |
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| Subject Categories | Culture, Education and Research, Health |
| Countries / Regions | Europe |
