Press Release: Commission unveils new rules to support gene, cell or tissue based therapies

The European Commission on 16 November 2005 proposed new EU wide rules to facilitate gene, cell and tissue-based therapies. These so-called advanced therapies enable revolutionary treatment of a number of diseases or injuries, such as cancer, Parkinson’s disease, skin in burn victims or serious cartilage damage. The Commission proposed a centralised marketing authorisation procedure, a new expert Committee, strengthened requirements for risk management and traceability and top-quality scientific advice. Ethical decisions about the use or non-use of germ cells or embryonic stem cells were to remain under the full responsibility of individual Member States.

• Primary Source

European Commission: Memo: MEMO/05/429, Advanced therapies: breakthrough in treating cancer or burned skin, 16.11.05 http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/05/429&format=HTML&aged=0&language=EN&guiLanguage=en

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