Europe drug regulation

It may not be entirely accidental that Stalinon and thalidomide were contemporary drugs and that both had neurotoxic potential. The story of thalidomide is too well known to bear much repetition here, but it is worth summarising it in the context of the development of drug regulation in Europe. The events that followed its clinical use were to provide the stimulus that laid the ground rules on which the Medicines Act in the UK and the legislation in most other modem European states, including the European Community s Directive 65/65/EEC, are based. 

Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation. 

The regulations also address the need to ensure that drug information provided by pharmaceutical firms is truthful, balanced, and accurately communicated. As such, it must be consistent with the indications for use and the established performance and limitations. In Europe, the directives do not impose a specific requirement to review advertising or promotional material before it is released. Acceptable standards may be achieved via voluntary codes of practice and self-regulation. However, national authorities must monitor such material and should have the power to act where the need arises. In the U S, the F DA must vet advertising and promotional material before it is released. 

Kaufer, E. (1990), The regulation of new product development in the drug industry , in G. Majone (ed.), Deregulation or Re-regulation Regulatory Reform in Europe and the United States, London Pinter Publishers. 

In Europe, the numbers of registered drugs and drug expenditure are increasing rapidly. Within the European Union (EU) there are no longer any regulations... 

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