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Drug Regulation in the Federal Republic of Germany

Published online by Cambridge University Press:  10 March 2009

Bernhard Schnieders
Bernhard Schnieders
Affiliation:
Federal Health Office, Federal Republic of Germany
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Extract

All drug evaluation and regulation policy in the Federal Republic of Germany is based on the Drug Law of 1976. In accordance with the pharmaceutical directives of the European Community, this law provided that all drug products must be of good pharmaceutic quality, therapeutically effective, and safe according to the current state of knowledge. It is aimed at guaranteeing safety in the use of drugs without hindering the plurality of thought in medical science.

Type
Special Section: The Evaluation of Drugs: An International Perspective
Information
International Journal of Technology Assessment in Health Care , Volume 2 , Issue 4 , October 1986 , pp. 643 - 649
Copyright
Copyright © Cambridge University Press 1986

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References

REFERENCES

1.Aus der Arbeit des Instituts für Arzneimittel. Bundesgesundheitsblatt, 1986, 28.Google Scholar
2. Law on the Reform of Drug Legislation, Federal Republic of Germany, August 24, 1976. Unofficial translation, Federal Ministry for Youth, Family Affairs and Health, F.R.G.Google Scholar
3.Schnieders, B. (ed.). Zulassung und Nachzulassung von Arzneimitteln: verfahren und Entscheidungskriterien nach dem Arzneimittel gesetz Internationale Vereinbarungen. Basel: Aesopus Verlag, in press.Google Scholar