[History of the evaluation of medicines aiming for marketing authorization].
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.
Caulin
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Service de Médecine Interne A, Centre Hospitalo-Universitaire Lariboisière, Paris. charles.caulin@lrb.ap-hop-paris.fr
D004358:Drug Therapy / Q000266:history*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007883:Legislation, Medical / Q000266:history; D040541:Marketing / Q000266:history* / Q000331:legislation & jurisprudence; D010297:Paris