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News

Patients look set to benefit from new tissue engineering regulations

MHRA : 04 June, 2007  (New Product)
European Health Ministers have reached agreement on a new regulation for 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', says Lord Hunt, Minister of State for Quality at the Department of Health.

'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'.

'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.
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