FDA Agrees to Share Info with Swedish Agency

PharmaManufacturing.com
05/02/2006

The Food and Drug Administration (FDA) and the Medical Products Agency (MPA) of Sweden announced Apr. 28 that they have signed a mutual Confidentiality Arrangement effective April 2006. The Arrangement allows the two Agencies to share certain non-public information, including law enforcement information and internal pre-decisional information.

"This is an important milestone," says Director General Gunnar Alvan of the Swedish MPA. "Drug approval processes and drug safety surveillance programs become more global by the day."

The Confidentiality Arrangement is useful when it comes to sharing drug safety data potentially resulting in regulatory measures we want to implement globally in a concerted manner. The difficulties experienced in simultaneous risk communications, due to the time difference between North America and Europe have effectively been alleviated.

"We are very pleased to participate in this Arrangement with the Swedish Medical Products Agency," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "The FDA is eager to work with our regulatory colleagues to establish mechanisms for sharing of important public health information and this arrangement will permit us to share drug safety surveillance and other non-public critical health information with an important European counterpart agency."