Healthy Skepticism Library item: 13499

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Caulin C.
[History of the evaluation of medicines aiming for marketing authorization].
J Fr Ophtalmol. 2008 Jan; 31:(1):71-4
http://www.masson.fr/masson/portal/bookmark?Global=1&Page=18&MenuIdSelected=106&MenuItemSelected=0&MenuSupportSelected=0&CodeProduct4=370&CodeRevue4=JFO&Path=REVUE/JFO/2008/31/1/ARTICLE120281938714.xml&Locations=

Abstract:

The European Directive on Medicines Evaluation and Marketing Authorization were issued in 1975. For more than 30 years, Marketing Authorization criteria have been defined as pharmaceutical and biological quality, therapeutic efficacy, and safety. The application comes from the pharmaceutical company and must include the full data on drug development. French procedures have always included practical assessment of the drug by health practitioners: clinicians, pharmacists, biologists, and specialists in biostatistics.