EMA and Swissmedic to Share H1N1 Medicine Information

Article

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines.

The European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines. The information will be shared as part of the agencies' regulatory and scientific processes both before and after a medicine has been approved.

According to a statement from the EMA, the agencies will exchange confidential scientific and technical information to ensure the safety, quality, efficacy and post-authorization follow-up of medicines used in the context of the H1N1 pandemic.

"This closer co-operation will provide two authorities earlier access to information on the basis for their respective recommendations on pandemic medicines and complete the overall view in their safety," said the EMA statement. "It will also create the opportunity to exchange experience regarding 'lessons learned' during the H1N1 pandemic."

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