European Medicines Agency Meets With Avian Flu Vaccine Manufacturers

Main Category: Bird Flu / Avian Flu
Also Included In: Pharma Industry / Biotech Industry
Article Date: 10 Mar 2006 - 1:00 PDT

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The European Medicines Agency has met with avian influenza vaccine manufacturers, European veterinary vaccine experts and representatives from the European Commission to promote the availability of authorised influenza vaccines for birds in the European Union.

The meeting held at the Agency's offices in London on 8 March 2006 considered the recent reflection paper from the Agency's Committee for Medicinal Products for Veterinary Use (CVMP) on data requirements for emergency avian influenza vaccines. There was consensus from all parties that the reflection paper should be developed into a full guideline as a priority.

As part of the Agency's preparedness for avian influenza, Thomas Lönngren, the Agency's Executive Director, has agreed to grant fee waivers for all applications made to the Agency for avian influenza vaccines. Waivers will be given for scientific advice, follow-up scientific advice, applications for marketing authorisation and variations relating to the pandemic use of the vaccine.

The CVMP has also recently adopted a guideline on accelerated assessment, which can be used by applicants for avian influenza vaccines. It was confirmed that the CVMP is committed to reviewing any application as quickly as possible, while still ensuring a scientifically sound and thorough assessment.

The meeting with interested parties is part of the Agency and the Committee's ambition to provide a clear route to rapid approval of influenza vaccines for use in birds throughout the European Union. This should in turn ensure the availability of safe and effective vaccines to Member States where they decide to use emergency vaccination within the context of their national control programmes against avian influenza.

The CVMP reflection paper on minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use in birds against H5 and/or H7 highly pathogenic avian influenza virus (EMEA/CVMP/IWP/46853/2006) was published on 16 February 2006 and can be found HERE.

This press release, together with other information on the work of the European Medicines Agency, can be found on the EMEA website: http://www.emea.eu

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