The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 28 November to 2 December 1994. The meeting was opened on behalf of the Director-General by Dr F.S. Antezana, Assistant Director-General, who emphasized the comprehensive role of the Expert Committee in dealing with a wide range of issues relating to the overall quality assurance of pharmaceutical products. In addition to the important task of elaborating and updating appropriate specifications for The international pharmacopoeia, he drew attention to other areas of the Expert Committee's work intended to assist WHO's Member States, especially developing countries. These included strengthening the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, advice on the establishment and management of drug testing laboratories, and recommendations on the function and structure of a small drug regulatory authority.
In May 1994, the World Health Assembly adopted resolutions WHA47.11-WHA47.17 related to drugs and pharmacy. It reaffirmed the principles embodied in the Expert Committee's documents concerning the role and functions of a small national drug regulatory authority and the WHO Certification Scheme, and approved the text on good manufacturing practices. It also requested the Director-General to continue the normative activities that provided standards to assure the quality, safety and efficacy of pharmaceutical and biological products. In this context, Dr Antezana drew attention to the complex issue of the registration of multisource products. He was confident that the Expert Committee would be able to offer advice in what was an area of great importance to many national drug regulatory authorities.
The Committee confirmed that the overall objective of its broad range of activities was to provide a foundation on which Member States could build a comprehensive approach to the quality assurance of pharmaceutical products. It believed that its role was to provide Member States with a technically sound but flexible model to serve as both a target and a framework for their regulatory activities. Member States would, of course, need to adapt specific elements of that model to local circumstances. A step-by-step approach to the implementation of individual guidelines was frequently advisable. Proper allowance could then be made for the stage of development of a particular regulatory system and the locally determined needs and priorities. The Committee emphasized that the aim was to assist Member States to develop an appropriate and sustainable quality assurance infrastructure in order to optimize the use of available resources. International and regional organizations should be encouraged to provide appropriate local training on the implementation of WHO guidance (developing strategies, adapting guidelines) and assistance in operating WHO schemes.