Moderator: Ms Malebona Precious Matsoso, South Africa

It has been stated that the aim of harmonization is to eliminate duplication and to ensure the efficient use of resources in order to allow faster access to safe and effective medicines of good quality. To this end, a number of guidelines have been developed, including those from the ICH. Non-ICH countries have, however, expressed a need to also develop a harmonization process for generic medicines.

A number of regional harmonization initiatives have been developed, and these experiences will be described. There is an understanding that harmonization initiatives should speed up access to medicines, while responding to the forces of international trade and achieving a balance between high technological requirements and public health needs.