The Pharmaceutical Journal
Vol 278 No 7451 p546
12 May 2007

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Centralised control planned for advanced therapies in EU

Centralised European Union authorisation for advanced therapies came a step closer last month when the European Parliament adopted a proposed Regulation.

The decision means that the three EU institutions — parliament, commission and the Council of Ministers — agree that a single regulatory process for gene therapy, cell therapy and tissue-engineered products should replace the current 27 separate national systems. The main elements of the planned Regulation include:

• A centralised marketing authorisation procedure

• A multidisciplinary expert committee for advanced therapies within the European Medicines Agency

• Tailored technical requirements to suit the characteristics of advanced therapies

• Strengthened requirements for risk management and traceability

• Special incentives for small- and medium-sized businesses

A spokeswoman from the European Organisation for Rare Diseases said the Regulation will benefit patients with uncommon disease through robust centralised assessment of safety, efficacy and quality of advanced therapies.