It was recognized that international harmonization is characterized by a number of initiatives undertaken in different parts of the world. Such initiatives reflect specific local or regional needs and circumstances. Although these activities and their products may be useful examples and supply important technical knowledge, no single initiative can currently be considered a model for international application or implementation.

1. Countries should take into account local factors, priorities, possible implications, and implementation capacity when evaluating harmonization initiatives and guidance materials produced elsewhere.

2. The development of international regulatory requirements and guidelines should be based on demonstrated public-health needs and should not be driven by technological progress alone.

3. WHO should continue to support regional and local harmonization initiatives aimed at strengthening regulatory capacity and achieving public health goals.

4. Progress should be reported back to the ICDRA.