Release date: 2007-06-05

ABHI Welcomes EU Decision on Advanced Therapies

(PRZOOM - Press & Newswire) —  London, United Kingdom, 2007-06-05 - The Association of British Healthcare Industries (ABHI) welcomes EU decision to adopt the Advanced Therapy Medicinal Products Regulation, harmonising the use of human tissue engineered products in the EU


On 31 May 2007 EU Health Ministers adopted the Advanced Therapy Medicinal Products (ATMP) Regulation, accepting the compromise package adopted on 25 April by the European Parliament.

The new Regulation will provide the long-awaited harmonised framework for the evaluation, authorisation and marketing of human tissue-engineered products in the European Union. Human tissue-engineering and the use of "smart" biomaterials that promote self-repair of damaged tissues offer tremendous promise for improved patient treatment, faster recovery, improved prognosis and a more biologically favourable situation where the body can be stimulated to heal itself.

ABHI Technical and Regulatory Director Mike Kreuzer said:
“ABHI welcomes the recent EU Council vote on the Advanced Therapy Regulation which paves the way for improved treatment using Regenerative medicine products which are already changing today's medical practice. Furthermore the ABHI ( supports the exclusion of tissue engineered products containing or made exclusively from non-viable human or animal cells which do not act as pharmaceuticals from the scope of the ATMP Regulation. Such products could well be covered by legislation based on the principles of the Medical Devices Directives which allow research and innovation to be encouraged and sustained whilst at the same time ensuring a high level of patient safety and equitable access to treatment.”

In its 2007 work programme, the European Commission has already envisaged the necessary steps to build a regulatory framework, based on the priciples of the MDD, for products excluded from the ATMP Regulation . As an active member of the European trade association Eucomed the ABHI will continue to work with the European Commission, the European Medicines Evaluation Agency (EMEA) and other stakeholders in order to develop the most appropriate regulatory regime.


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