Moderators: Mr P Deboyser European Union, and Mr M. Dauramanzi, Zimbabwe

Based on some thirty-eight available tripartite guidelines dealing with numerous principles of quality, safety and efficacy requirements for new medicinal products, the International Conference on Harmonization (ICH) has now prepared a common technical document (format and content of a new drug application) which harmonizes part of the documentation required for a new drug application.

Due to existing practices, traditions and regulations, many administrative requirements and aspects of product labelling vary between ICH countries. Moreover, there are differences in the overview summaries for scientific documentation, the need for individual clinical case reports, and the data to document findings made in animal studies. These and other special local requirements form a substantive portion of an application for marketing authorization and remain, in principle, outside the current CTD concept.

It is understandable that multinational pharmaceutical companies would also like to use the CTD outside ICH countries. To achieve more extended acceptance of the CTD, WHO has offered assistance to the ICH through its international consultative mechanism and by involving non-ICH countries in discussions on CTD harmonization. Thus, pharmaceutical advisers from each of the six regions of WHO have participated in CTD expert working groups since 1998. Their role has been to assist in distribution of relevant working documents to drug regulatory authorities within their own region for comment to assure wider participation in this exercise.