In 1965 the first EEC Directive on the approximation of the national provisions related to medicinal products (65/65/EEC) stipulated, beside others, that the application for registration shall contain results of clinical trials.
Ten years later Directive 75/318/EEC ensured uniform standards and protocols for the performance of test and trials, especially clinical trials.
In May 1987 the CPMP Recomended Basis for the conduct of clinical trials addressed the general norms and scientific principles for the conduct, performance and control of clinical trials of medicinal products.
Based on 75/318/EEC and on CPMP Recommended Basis, intensive discussions continued in order to further impure the measures to thorough protect the rights and integrity of the trial subjects, to establish the credibility of data, and to improve the ethical, scientific and technical quality of trials.
Mots-clés Pascal : Recommandation, Législation, Exploration clinique, Essai clinique, Médicament, Allemagne, Europe, CEE
Mots-clés Pascal anglais : Recommendation, Legislation, Clinical investigation, Clinical trial, Drug, Germany, Europe, EEC
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0478588
Code Inist : 002B02A. Création : 199406.