US and Swedish regulators sign information-sharing agreement

The US Food and Drug Administration (FDA) has signed a mutual confidentiality arrangement with the Swedish Medical Products Agency (MPA) that will assist with the agencies" drives towards more global drug approval and monitoring processes, helping to alleviate "difficulties experienced in simultaneous risk communications, due to the time-difference between North America and Europe".

The agreement will allow the two agencies to share non-public information on areas including law enforcement, drug safety and "internal pre-decisional information"

"We are very pleased to participate in this arrangement with the Swedish MPA," said acting FDA commissioner, Dr Andrew C von Eschenbach. "The FDA is eager to work with our regulatory colleagues to establish mechanisms for sharing 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."

Gunnar Alvan, director general of the Swedish MPA, described the arrangement as "an important milestone" in an age of increasingly global drug approval processes.