www.fdanews.com/articles/74619-france-plans-new-post-launch-regulation
FRANCE PLANS NEW POST-LAUNCH REGULATION
July 25, 2005
French healthcare regulator AFSSAPS is to create a new unit to monitor drug safety after marketing approval has been given, with new checks on promotional material and patient information.
The new body, which is expected to begin operations in two months' time, will attempt to manage risks and ensure proper consumption. Meanwhile, the agency's existing team will attempt to expand efforts to monitor adverse reactions after product launch.