Challenges in International Harmonization

Abstract

This paper covers the challenges that regulatory agencies face with regard to international harmonization. The International Conference on Harmonization (ICH) process, while very successful, has raised a number of issues that must be dealt with. Trade agreements such as the General Agreement on Tariffs and Trade (GA TT) and the North American Free Trade Agreement (NAFTA) raise other issues. The FDA's international activities, as well as its resources and priorities, are described. Examples of FDA challenges currently being dealt with are provided.