March 10, 2006

EU drug regulator meets bird flu vaccine makers

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

The parties considered the recent reflection paper from the Agency's Committee for Medicinal Products for Veterinary Use on data requirements for emergency bird flu 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 bird flu, Thomas Loenngren, the Agency's Executive Director, has agreed to grant fee waivers for all applications made to the Agency for bird flu 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 meeting with interested parties is part of the Agency and the Committee's ambition to provide a clear route to rapid approval of flu vaccines for use in birds throughout the EU.

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 bird flu.