On 31 May 2007, agreement was reached by European Health Ministers on a Regulation on advanced therapy medicinal products (ATMPs), including tissue engineering.

"This Regulation will provide a secure legislative framework for those involved in developing innovative ATMPs which will benefit patients across Europe. This is good news for industry and for patients. We are grateful for the many interested parties who have worked constructively with the MHRA during the negotiations in order to secure a good outcome for the UK." says Lord Hunt, Minister of State for Quality at the Department of Health.

"This Regulation will enable patients across Europe to have access to safe and effective therapeutic treatments. It will also provide regulatory certainty for the biomedical research industry, currently developing some of the most ground-breaking medicines of our time." says Aisling Burnand, Chief Executive of the BioIndustry Association.

ATMPs are innovative, regenerative therapies which combine aspects of medicine, cell biology, science and engineering for the purpose of regenerating, repairing or replacing damaged tissue/cells. The use of this technology has already led to the development of products that are used clinically for the treatment of burns or ulcers and cartilage repair systems used in the treatment of early arthritis. More complex products are currently being developed for the treatment of heart disease and other degenerative conditions.

The overall aim of the new Regulation is:

-- to improve patients' access to ATMPs;
-- to provide legal certainty in order to foster development in the European biosciences industries; and
-- to harmonise market access in the European Union by establishing a comprehensive regulatory framework for ATMPs.

The Regulation provides for a centralised authorisation procedure for marketing of these innovative products. A range of incentives is proposed including reduced fees payable to the European Medicines Agency (EMEA) for scientific advice. The Regulation recognises that there is no consensus among Member States upon which harmonised decisions could be taken on the use or prohibition of ATMPs containing certain types of cells (such as embryonic stem cells) so this would remain a national responsibility.

It is expected that the Regulation will come into force by the end of 2007. Detailed information about the Regulation is available on the European Commission's website, please click here. A copy of the text will be posted on the MHRA website once it is available.

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem.

-- Press release: New European regulation on tissue engineering to benefit patients


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