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European framework adopted on "Advanced Therapies" will allow European-wide access to a new generation of treatments

04 Jun 2007 - EU Health Ministers decided to forge ahead with a new EU system for the centralized review and approval of all gene, cell and tissue based therapies in the European Union. They voted in favour of a proposed EU Regulation on Advanced Therapies, accepting the Compromise Package proposed by the European Parliament. This means that Europe will now have a harmonized legal framework in place for these innovative products that could start as early as next year (January 2008).
 
"The Advanced Therapies Regulation provides Europe with a great advantage to attract the leading companies researching and developing these innovative therapies and providing the scientific community, patients and industry with a predictable and clear legal framework," says Andrea Rappagliosi, Chair Healthcare Council at EuropaBio - the EU Association for Bioindustries.
 
The Regulation means that all advanced therapies can receive a single EU Marketing Authorisation, valid throughout Europe, following a scientific evaluation by a new Committee of Advanced Therapy (CAT) experts at the EMEA. The single, centralized authorization will give patients the opportunity to benefit from this new generation of treatments, while at the same time ensuring that they meet Europe-wide common safety and efficacy standards.
 
The single system will replace the existing patchwork of 27 differing standards, which hampers research and development and stops patients being able to benefit from the fruits of this new sector.
 
The Regulation text now still needs to be translated and undergo standard legal and linguistic checks before being formally published in the EU Official Journal but the Council decision means that this formality can start directly.
 
The next stage will see the development of the secondary-level implementing legislation and the Technical Guidelines. EuropaBio members look forward to the timely setting in place of the required technical guidance and continuing to work with the European Commission and the EMEA on these issues, together with all other stakeholders. The implementing rules along with continued adequate funding for the EMEA are vital to ensure that Europe can develop a world-class science-based system for these products.