Proposed Regulation on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (link)

November 17, 2005

Brussels, 16 Nov 2005

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 {SEC(2005) 1444}
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The current picture

The advancement of science in the fields of biology, biotechnology and medicine, has fuelled the development of promising gene- and cell-based approaches for the prevention and treatment of diseases or dysfunctions of the human body. A number of gene therapy and somatic cell therapy products are already being tested at clinical level for the treatment of inherited diseases, cancer, diabetes, Parkinson's disease and other neurodegenerative disorders.

In addition, a new biotechnology area has emerged: tissue engineering, which combines various aspects of medicine, cell and molecular biology, materials science and engineering, for the purpose of regenerating, repairing or replacing human tissues. Current applications of this nascent field of "regenerative medicine" include treatment for skin, cartilage and bone diseases or injuries. More complex products are already in development, and could reach the Community market in a near future1.

Advanced therapies: a coherent ensemble

These three kinds of advanced therapies (gene therapy, somatic cell therapy, and tissue engineering) are expected to have a major impact on public health, by improving the quality of life of patients and changing medical practice significantly. Moreover, they constitute a coherent ensemble insofar as they share several key scientific, regulatory and economic features:

­ They are based on complex, highly innovative manufacturing processes. The specificity of the product precisely lies in the process.

­ Regulatory and scientific expertise for the evaluation of advanced therapies is scarce: pooling of that expertise at Community level is therefore essential to ensure a high level of public health protection.

­ Traceability from the donor to the patient, long-term patient follow-up and a thorough post-authorisation risk management strategy are crucial aspects to be addressed when evaluating advanced therapies.

­ Advanced therapy products are usually developed by innovative small and medium-sized enterprises, highly-specialised divisions of larger operators in the Life Science sector (biotechnology, medical devices and pharmaceuticals), hospitals or tissue banks. They are subject to rapid and often radical innovation.

See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.: `Human tissue-engineered products - Today's markets and future prospects', Joint Research Centre - Institute for Prospective Technological Studies (European Commission), EUR 21000 EN, October 2003. The current regulatory gap and its implications on public health

Despite these common elements, the regulatory picture for advanced therapies remains incomplete. In particular, while products intended for gene and somatic cell therapy have been classified as medicinal products and regulated as such in the Community2, tissue-engineered products currently lie outside of any Community legislative framework. This leads to divergent, national approaches as to their legal classification and authorisation, thereby impairing the free movement of tissue engineered products in the Community, and hindering patients' access to these innovative therapies.

There is therefore a need to bridge the regulatory gap by addressing all advanced therapies - including in particular tissue engineering- within a single, integrated framework, fully taking into account their scientific and technical characteristics as well as the specificities of the economic operators concerned.


Brussels, 16.11.2005 COM(2005) 567 final 2005/02 (COD) Previous Item Back to Titles Print Item

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