(1997; 248 pages) [French]
1. General considerations
Small countries which have yet to introduce comprehensive legal provisions for drug regulation can draw from a diversity of national systems in determining their own requirements. None the less, problems in establishing drug control in developing countries have too often resulted from the adaptation of provisions successful elsewhere but of a complexity that precludes their effective implementation in the country of adoption. It is of paramount importance that legislation and administrative practices are attuned to available resources and that every opportunity is taken to obtain and use information provided by regulatory authorities in other countries on pharmaceutical products and substances moving in international commerce.
Channels of communication between national regulatory authorities are improving, as is evident from the information contained in WHO’s monthly Pharmaceuticals newsletter, the quarterly journal WHO drug information, and the United Nations Consolidated List of Products Whose Consumption and/or Sale have been Banned, Withdrawn, Severely Restricted or Not Approved by Governments. Moreover, many difficulties inherent in storing, retrieving and analysing data that subserve the many facets of the regulatory process can now be overcome by the use of microcomputers and commercial software packages.