1. Globalization of International Conference on Harmonization (ICH) guidelines should be further pursued as appropriate for Member States. WHO should continue to play an important role by taking into account the implications for non-ICH members.
2. WHO should explore the feasibility of integrating ICH products and WHO guidelines into a comprehensive set of guidelines.
3. Countries should take into consideration local factors in applying ICH guidelines.
4. ICH should give greater consideration to developing country needs through WHO particularly as this relates to the quality of all medical products including generic and over-the-counter (OTC) drugs. Mechanisms should be established to increase the balanced participation of developing countries in the consultative process of ICH. Non-ICH countries should actively seek opportunities to participate by reviewing documents under development and submitting comments early in the process, as appropriate.
5. ICH guidelines may be utilized by interested parties as a source of education and training.
6. Since ICH guidelines cover new products and many countries manufacture, register and use generic drugs, WHO is encouraged to continue work on guidelines on requirements for registration of generic drugs.
7. ICH updates should remain a subject for future ICDRAs and related WHO-sponsored regional meetings.