The development of good clinical practice in the EEC and in Germany

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 Recommended 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 improve the measures to thoroughly 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. As a result of these negotiations CPMP adopted in 1990 the note for guidance: GCP for Trials on Medicinal Products in the EC. In July 1991 Directive 91/507/EEC modifying 75/318/EEC was issued. It adopts the requirements to prove quality, safety and efficacy to the latest state of the art. The German Drug Law (AMG) from 1976 transposed 65/65/EEC in its substantial parts. AMG contains its own section called "Protection of the human being during the clinical trial", which only stipulates a list of general conditions to be fulfilled before starting the trial. In Dec. 1987 German Health Ministry (BMG) published a paper on the orderly execution of clinical trials to establish rules on the planning, execution, evaluation and documentation of clinical trials (BMG Principles).(ABSTRACT TRUNCATED AT 250 WORDS)