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European regulation tackles tissue engineering

Nature Biotechnology volume 25, pages 1089–1091 (2007)Cite this article

To the editor:

The term 'Advanced Therapy Medicinal Products' (ATMPs) was first introduced in Part IV of Annex I to Directive 2001/83/EC as amended by Directive 2003/63/EC on the European Community code relating to medicinal products for human use2,3. Whereas gene therapy and somatic cell therapy medicinal products have already been classified as ATMPs under this framework, the new legislation also defines tissue-engineered products (TEPs) as a third group of ATMPs4,5, providing a unified legal instrument for overseeing these biologic products. The integration of TEPs as medicinal products was suggested on the basis of a 2005 study, conducted by the Institute for Prospective Technology Studies from the Joint Research Centre of the European Commission (JRC-IPTS), which indicated that the lack of European-wide legislation for TEPs has led to divergent national procedures6. Today, certain European Union (EU; Brussels) member states classify TEPs as medicinal products, whereas others classify them as medical devices, resulting in prohibitive inconsistency and uncertainty among manufacturers and legislative bodies on how TEPs should be treated, commercialized and placed on the European market.

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References

  1. European Parliament. European Parliament Legislative Resolution of 25 April 2007 on the Proposal for a Regulation of the European Parliament and of the Council on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (COM(2005)0567–C6-0401/2005–2005/0227(COD) (European Parliament, Strasbourg, April 25, 2007). <http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P6-TA-2007-0144+0+DOC+XML+V0//EN>

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Authors and Affiliations

  1. Division of Medical Biotechnology, Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines, Paul-Ehrlich-Strasse 51–59, D-63225 Langen, Germany. sanra@pei.de or floeg@pei.de,

    Ralf Sanzenbacher, Martina Schuessler-Lenz, Klaus Cichutek & Egbert Flory

  2. Department 115—Blood and Blood Products, German Ministry of Health, Sera, Vaccines and Tissues, Am Probsthof 78a, D-53121, Bonn, Germany

    Anne Dwenger

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Sanzenbacher, R., Dwenger, A., Schuessler-Lenz, M. et al. European regulation tackles tissue engineering. Nat Biotechnol 25, 1089–1091 (2007). https://doi.org/10.1038/nbt1007-1089

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