Guidelines for evaluation of drugs for use in man : report of a WHO scientific group - WHO Technical Report Series, No. 563 (Russian version)
(1975; 72 pages) [English] [French] [Spanish]


The introduction of a large numbers of new drugs during recent decades has caused concern among the medical profession, research workers in the drug field, and the public in regard to both safety and efficacy. But it was not until the tragic effects of thalidomide in the early 1960s that the procedures employed, which left evaluation of the safety and efficacy of drugs largely in the hands of the drug manufacturers and clinicians, were recognized as inadequate. Legislation governing the evaluation of both new and old drugs has now been adopted in many countries.

The manner in which the World Health Organization can contribute to an improvement in drug evaluation has been discussed at various sessions of the governing bodies of WHO. The present Group was convened to consider all aspects of the evaluation and testing of drugs in the light of increasing knowledge and to formulate proposals and guidelines for present and future research in the field.

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