International guidelines on post-authorisation research and surveillance. European Economic Community.
Recently, post authorisation research and surveillance has become more and more important. This article investigates which common standards already exist and which methods and tools are used in this context. This paper focusses on a draft version of the "Notice to applicants for marketing authorisations for medical products for human use in the European Community" which will be mandatory for all EC member countries after its finalization.
Herbold
M
M
Hoechst Pharma Deutschland (HPD), Bad Soden am Taunus, Germany.
D017277:Drug Approval; D004345:Drug Industry; D005062:European Union; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012107:Research Design