(2000; 28 pages) [French]
8.2 Drug regulation
After approval of a medicinal product, all available domestic and international safety information is continuously monitored by the drug regulatory authority and the pharmaceutical company concerned. Often problems can be solved by adaptation of the approved product information (inclusion of new adverse effects, warnings, or indication changes). Sometimes stronger restrictive actions are needed, with withdrawal of the marketing authorisation as the extreme. For the approval of a given drug in a given country, it may be very helpful to have information on the experiences with the drug in countries where it is already in use (e.g. through collaboration with the Uppsala Monitoring Centre).