The World Health Organization (WHO) has traditionally supported the process of international harmonization by directing and coordinating health work and in encouraging technical cooperation. The Organization has been involved in a number of important harmonization activities having a major impact on the development, production and regulatory control of pharmaceutical products. Among these, the preparation of specifications and guidelines for the quality assurance, safety and efficacy of pharmaceutical substances has been carried out in close collaboration and consultation with Member States.

New regional and interregional harmonization activities related to drug regulation are now under way in many parts of the world and, as this situation unfolds, it is clear that the establishment of international standards needs more than ever to be focused on interests of public health. Possible options for the continued involvement of WHO in the international harmonization of drug regulatory activities were recently evaluated in a report developed by a WHO independent review team*. The report highlights the urgent need for WHO to sustain regional and international harmonization efforts through greater participation in activities under development.

The report discusses two main areas of harmonization. The first concerns regional harmonization currently in progress throughout the world. The second, which is summarized below, addresses the respective roles of WHO and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) involving the harmonization efforts of regulatory requirements of pharmaceuticals in the European Union, Japan and the United States of America. The report proposes options for the future role of WHO.