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Published on 11 March 2008

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EMEA optimistic after record year


The EMEA received a record number of requests for regulatory approval last year, figures show.

These included initial marketing authorisations, post-authorisation variations and requests for scientific advice relating to medicines for human use.

The watchdog’s annual report also reveals that a greater number of positive opinions were adopted, and despite the high volume of applications these were all evaluated within the correct timescales.

The EMEA received 90 applications for marketing authorisations for medicines for human use last year, 12 more than in 2006 – including 11 applications for orphan medicines, 10 for generics and 10 for biosimilars.

One application was also made for a scientific opinion on a medicinal product intended for use outside the EU, as part of the organisation’s efforts to support developing countries.

A statement said: “The EMEA will continue to support EU-wide efforts to facilitate research and innovation, mainly through participation in the work of the Innovative Medicines Initiative, for human medicines, and the European Technology Platform for Global Animal Health, for veterinary medicines.

“Efforts to reinforce a proactive approach to the monitoring of the safety of medicines will remain high on the agency’s agenda, including initiatives to be undertaken in the context of the European Risk Management Strategy (notably the ENCePP project), the further development of EudraVigilance databases, and the improvement of the concept of risk-management plans for human medicines.”

Copyright © PA Business 2008


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