The European Medicines Agency and Swissmedic, the Swiss Agency for Therapeutic Products have agreed to share information on H1N1 pandemic medicines.
The two agencies will from now on be able to exchange confidential information about the authorisation and safety of medicines used to treat patients affected by H1N1 pandemic influenza.
The confidentiality arrangement signed on 12 February 2010 is designed to allow for a greater exchange of confidential scientific and technical information to ensure the safety, quality, efficacy and post-authorisation follow-up of medicines used in the context of the pandemic.
Closer co-operation will provide the two authorities with earlier access to information on the basis for their respective recommendations on pandemic medicines as well as providing shared safety information.
According to the EU the partnership will also create the opportunity to exchange experience regarding “lessons learned” during the H1N1 pandemic.
The arrangement will allow the exchange of information before and during regulatory and scientific processes, before and after a medicine has been approved.
