A Swedish Regulatory Perspective on European Risk Management
2007 (English)In: International Journal of Pharmaceutical Medicine, ISSN 1364-9027, Vol. 21, no 2, 131-145 p.Article in journal (Refereed) Published
Worldwide, drug regulation safety requirements in the past can be seen as responses to major drug disasters, such as thalidomide or diethylstilbestrol. In the light of the more recent drug disasters, the public is less willing to accept risk associated with drug therapy. Increased emphasis has to be placed on the proactive identification of potential safety issues with new drugs at the earliest possible occasion, and before large populations have already been exposed to the drug. The concept of balance between potential benefit and risk also has to be communicated more strongly.This article presents an overview of spontaneous reporting systems and signal detection and evaluation. It also discusses regulatory issues and risk management with an emphasis on the new European Community system. A number of new initiatives and obligations are introduced that are handled by the European regulatory agencies.
Place, publisher, year, edition, pages
2007. Vol. 21, no 2, 131-145 p.
Legislation, Pharmaceutical risk management, Pharmacovigilance, Regulatory process
IdentifiersURN: urn:nbn:se:uu:diva-123669OAI: oai:DiVA.org:uu-123669DiVA: diva2:315450