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The Regulation of Drugs: Worlds of Difference

Published online by Cambridge University Press:  10 March 2009

M. N. G. Dukes
Affiliation:
University of Groningen, The Netherlands

Extract

It is difficult to determine when drug regulation began. The idea that some kind of control is necessary is very old indeed; it was many centuries ago that apothecaries were first accused of paternalism and secrecy, and it was just as long ago that they found arguments to present their case as guardians of the public interest. It was at least three centuries ago that regulations on the sale of opiates were first devised in order to protect the ignorant, the reckless, and the exploited.

Type
Special Section: The Evaluation of Drugs: An International Perspective
Copyright
Copyright © Cambridge University Press 1986

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References

REFERENCES

1.Anonymous, . Aleotti on “death” of Italian industry. Scrip, 1984, 905, 1.Google Scholar
2.Bruun, K. (ed.) Läkemedels frógan i norden. Stockholm: Bokförlaget Prisma, 1982.Google Scholar
3.Buitendijk, S. DES–The time-bomb drug. In Drugs in pregnancy and delivery—report on the Thirteenth European Symposium on Clinical Pharmacological Evaluation in drug control. Copenhagen: World Health Organization, Regional Office for Europe, 1984.Google Scholar
4.Cook, R., Schearer, S. B., & Strand, J.Contraceptives and drug regulation: an international perspective. Piact Papers, 1982, 7, 138.Google Scholar
5.Cromie, B. Present problems: the effects of British regulations. In Medicines for the year 2000. London: Office of Health Economics, 1979.Google Scholar
6.Dukes, M. N. G. Pharmaceuticals: take another look. Inaugural Lecture, Unit for Drug Policy Science, University of Groningen, 1985.Google Scholar
7.Dukes, M. N. G.The effects of drug regulation. Lancaster: MTP Press, Ltd., 1984.Google Scholar
8.Dukes, M. N. G., & Lunde, I.Review of restrictive actions under the Australian drug regulatory system. Medical Journal of Australia, 1982, 1, 412–16.CrossRefGoogle ScholarPubMed
9.Dukes, M. N. G., & Lunde, I.The regulatory control of non-steroidal anti-inflammatory agents. European Journal of Clinical Pharmacology, 1981, 19, 310.Google Scholar
10.Dukes, M. N. G., & Lunde, I.Controls, common sense and communities. Pharmaceutiesch Weekblad, 1979, 114, 1283–94.CrossRefGoogle Scholar
11.Gelzer, J.Government toxicology regulations: an encumbrance to drug research? Archives of Toxicology, 1979, 43, 1926.CrossRefGoogle Scholar
12.Grabowski, H.Public policy and innovation: the case of pharmaceuticals. Technovation, 1982, 1, 157–89.CrossRefGoogle Scholar
13.Granat, M., Joldal, B., & Sjöblom, T.The processing of applications for the registration of medicines in the Nordic countries. Journal of Social and Administrative Pharmacy, 1983, 1, 3444.Google Scholar
14.Haayer, F. M., van der Werf, G. Th., Wieringa, N. F., & Wesseling, H.Use of cimetidine: parallels and discrepancies between the views of drug regulatory agencies and practising physicians. European Journal of Clinical Pharmacology, 1983, 25, 601–7.Google Scholar
15.Hass, A. E. Jr, Marketing patterns of top-selling new drugs in eleven countries. FDA Office of Planning and Evaluation, 1983, unpublished.Google Scholar
16.Klaes, L., Seebach, R., Lex, C., & Feick, J. Regulative Politik und politisch-administratve Kultur. En Vergleich von fünf Ländern und vier Interventionsprogrammen. Institut für angewandte Sozialforschung, Universität zu Köln, 1982, unpublished.Google Scholar
17.Lunde, I., & Dukes, M. N. G.The concept of geriatric drugs: a regulatory dilemma. Pharmacy International, 1982, 9498.Google Scholar
18.Quantock, D. C. The effect of regulation on international drug development. In Harcus, A. W. (ed.), Risk and regulation in medicine. London: Association of Medical Advisers in the Pharmaceutical Industry, London: 1980.Google Scholar
19.Schmidt, A.The FDA today: critics, congress and consumerism. Speech to National Press Club, Washington, D.C., 10 29, 1974.Google Scholar
20.Wardell, W. W. Regulation and pharmaceutical innovation: a review of the relationship between government regulation aimed at protecting health and human safety, and innovation leading to medically useful drugs, 1976, unpublished.Google Scholar