Authors: Meneguz, Annarita
Article Type:
Research Article
Abstract:
Following the opinion of the European Parliament on 25 April 2007, the European Council of Ministers approved the Regulation on Advanced Therapies Medicinal Product (ATMP) [1]. The Regulation was translated into all EU official languages and on 30 October 2007 the Advanced Therapy Regulation was formally adopted by the EU Council. The Regulation was published in the EU Official Journal on 10 December 2007. From December 30, 2008, the new European Regulation, (EC) No 1394/2007, applies.
…This means that Europe has now a common legislation for this type of products which have previously been handled differently in different countries. For the first time, the ATMP Regulation brings all "advanced therapies" (gene, cellular and tissue-based treatments) together within a single, integrated European regulatory framework, in order to ensue consistency across member states. The implementation plan of ATMP Regulation has been developed and agreed with the European Medicines Agency (EMA), and the a new scientific committee, the Committee on Advanced Therapy (CAT), has been created at the EMA to assess quality, safety and efficacy of advanced medicinal products and to follow scientific developments in the field. The committee will also provide scientific advice to companies developing advanced therapy medicinal products. In Italy it is established that the standard for ATMP development and clinical trials should follow both the specific tailor-made technical requirements of the Regulation and those defined by European Directives on clinical trials, "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use" [2] and "Directive 2005/28/EC, laying down principles and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" [3]. This implies that GXP rules [Good Manufacturing Practice (GMP) for production, Good Laboratory Practice (GLP) for non clinical safety studies and Good Clinical Practice (GCP) for registration clinical trials] should be followed during development.
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Keywords: Advanced Therapies Medicinal Product, GMP, GLP, GCP, SOP
DOI: 10.3233/PPL-2010-0261
Citation: Pharmaceuticals, Policy and Law,
vol. 12, no. 1-2, pp. 29-33, 2010
Price: EUR 27.50
