Globalization and Harmonization of Regulatory Issues: The Who Perspective of Developing Countries' Needs and Perspectives

Abstract

This paper covers the World Health Organisation's (WHO's) role in global harmonization and its relation to the ongoing International Conference on Harmonization (ICH) process, developing countries' needs as perceived by the World Health Assembly, and examples of WHO's normative activities and support to national drug regulatory authorities. Global harmonization will result in improved safety worldwide, facilitate international trade, and save scarce resources.