This day-long session deals with the important topic of international harmonization. Harmonization is relevant to all levels of drug regulatory affairs - global, multilateral and regional - and topics for harmonization abound. This is why our real challenge lies in dealing with the most relevant aspects of harmonization for our regulatory work. But first of all, I would like to remind you of the reason why this session is on the agenda and what we hope to accomplish.

It was agreed at previous International Conferences of Drug Regulatory Authorities that we would provide an update on this topic in forthcoming conferences. Furthermore, the World Health Assembly has strongly endorsed harmonization activities and, in particular, has recognized the progress made in the International Conference on Harmonization (ICH) and the need for involvement of all parties - not just the ICH members and observers. Both ICH 2 and ICH 3 stressed the importance of transparency and the need for utilization of the adopted tripartite guidelines beyond the ICH partnership and it has been WHO's role, as an ICH observer, to promote globalization, as appropriate. ICH has now reached a stage where it is important for drug regulatory authorities worldwide to learn of the current status of the ICH, its direction, and WHO's involvement, and to be able to participate in the discussion in order to maximize effectiveness.

This session is therefore organized to permit WHO to describe its many activities related to international harmonization. The tripartite ICH members will then be allowed to describe progress in the specific working groups, and this is followed by an appropriate response from speakers outside the tripartite initiative. Following the subsequent presentations describing regional harmonization activities, a panel will respond to questions from participants. We are extremely fortunate to have assembled such an outstanding group of speakers to participate in this session.

We are going to hear about a broad range of harmonization activities related to the regulation of pharmaceuticals which have major implications for public health. Most are scientific or technical, but others are trade-related. All these topics are relevant and I urge you to take part in the sessions in whatever way you see fit in order that we may all benefit from a truly rewarding dialogue.

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