Clinical Guidelines for the Assessment and Evaluation of Drugs

Abstract

At the sixth meeting on Clinical Pharmacological Evaluation in Drug Control, organized by the WHO Regional Office for Europe, it was stated in the “Recommendations” that “the standards and requirements imposed by drug control authorities should be disseminated in the form of concrete guidelines. …various guidelines of this kind, applicable to drugs as a whole or to specific product groups, have been and are being developed both by national organizations and by regional bodies (Benelux, CMEA, EEC). The time is now ripe for steps to be taken to coordinate these activities in order to avoid unnecessary discrepancies. WHO should therefore take measures to collect and compare guidelines of this type and to encourage consultation between the authorities responsible for them. In particular, guidelines for specified groups of drugs can be taken as a basis for discussion at future symposia.”¹