Regulation No 1394/2007 on advanced therapy medicinal products will enter into force on 30 December 2007 and will apply from 30 December 2008. The Regulation amends the Community code relating to medicinal products for human use (Directive 2001/83/EC) and the Regulation setting out the Community authorisation procedures for medicinal products (No 726/2004).
The purpose of the Regulation is to facilitate research, development and authorisation of advanced therapy products and to improve patient access to them. The Regulation covers new forms of treatment such as gene therapy, somatic cell therapy and tissue engineering which are neither drugs nor surgery as traditionally defined. Gene and cell therapies are currently being tested at a clinical level for the treatment of specific genetic diseases, rare cancers and other neurodegenerative disorders. Tissue engineering combines various aspects of medicine, biology and engineering, to produce, repair or replace human tissues. Tissue engineering can use human or animal cells or tissues or a combination of them and may also use other bio-materials and molecules or chemical substances, scaffolds or matrices. These new therapies have enormous potential to improve the quality of life of patients.
However, advanced therapies are based on complex and new manufacturing processes and the creation of an EU regulation is a way of addressing this complexity by offering a framework to support advancement and to ensure patient safety. The Regulation creates a centralised European marketing authorisation process for the authorisation, supervision and pharmacovigilence of advanced therapy medicinal products. The Regulation also creates a Committee for Advanced Therapies (CAT) within the European Medicines Agency to bring together expertise from different Member States to enable the evaluation of such products and to provide advice on the authorisation process, long-term follow-up of patients and risk management strategies for the post authorisation phase. CAT will be in charge of developing criteria and guidelines for the evaluation of these products.
The recitals to the Regulation state that it should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells, such as embryonic stem cells or animal cells. Furthermore, it should not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting or derived from these cells.
The Regulation applies existing Community legislation with respect to donation, procurement and testing of human cells or tissues, clinical trials, good manufacturing practice and medical devices. It sets out the evaluation, labelling and post-authorisation procedures for advanced medical products. There are also transitional provisions for advanced therapy medicinal products and tissue engineered products that are legally on the Community market when the Regulation comes into force, these products must comply with the Regulation by 30 December 2011 and 30 December 2012 respectively.
Further information can be found at the EMEA medicines and emerging science website: http://www.emea.europa.eu/htms/human/mes/advancedtherapies.htm and the Commission's website for the Regulation: http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/index.htm