The International Regulatory Affairs team in Maidenhead supports all products in development or on the market outside the USA.

 

For our development programs, the International Regulatory Affairs team is responsible for providing strategic input to the global clinical development teams about the regulatory climate in the EU and elsewhere, and for provision of regulatory advice to the teams. The International Regulatory team also makes clinical trial applications to each country where the studies will be conducted. We are now conducting clinical development work in approximately 50 countries.

 

Our International Regulatory team also generates Market Authorisation Applications for Europe and many other countries in close collaboration with our local teams and is responsible for both assisting our subsidiaries and distributors to achieve the initial license approvals and following approval, for supporting the filing and approvals of lifecycle enhancements of our marketed products outside the US.  Biogen Idec now markets Avonex in over 90 countries and Tysabri in more than 30 countries.

 

In all of our work, we collaborate very closely with the International Headquarters in Zug, Switzerland and with the other parts of the Global Regulatory team which are based in Cambridge Massachusetts and San Diego California.