Affiliations: Dipartimento del Farmaco ISS, Rome, Italy. E-mail:
[email protected]
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.
