[Approval of drugs by national and European agencies--from the viewpoint of drug approval committee A].
The German Medicines Act was issued in 1976 (1 1/2 decades after the thalidomide tragedy) and intends the installation of a non-governmental commission A, recruited of independent external experts, before a new drug is licensed. All medical and pharmaceutical disciplines are represented in this non-governmental commission A. They are elected and empowered by the minister of health for three years. The non-governmental commission A examines independently all applications of new drugs. It is part of the licensing process rather than an advisory committee. In case the vote of the non-governmental commission A differs from the regulatory authority, the latter takes the final decision but has to submit its argumentation for the different evaluation. This separation of the competence of decision making between the authority and the external experts constitutes a novum in the German legislation as well as worldwide. The discussions and votes of the non-governmental commission A are confidential. Some experiences on the work of the non-governmental commission A are dealt with in more detail.
Henschler
D
D
Institut für Toxikologie, Universität Würzburg.
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D005858:Germany; D006801:Humans; D010606:Pharmacy and Therapeutics Committee / Q000331:legislation & jurisprudence*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence
Zulassung von Arzneimitteln durch nationale und europäische Behörden--aus der Sicht der Zulassungskommission A.