(2002; 166 pages)
1. WHO should continue involvement in the ICH Steering Committee, adopting a more proactive role by proposing topics for guideline development and expressing opinions on the potential public health implications of the guidelines proposed by ICH.
2. In the light of the wide range of regulatory environments, WHO should support non-ICH Member States and regional harmonization initiatives by evaluating the usefulness, feasibility and impact of implementing ICH guidelines.
3. WHO should continue to produce briefing notes on ICH meetings for regulatory officials of non-ICH countries and consider ways of making them widely available, including use of the Internet.
4. In order to improve access to essential drugs of good quality, especially in developing countries, WHO should assess the benefits and risks to public health of implementing selected ICH drug quality guidelines on manufacturing standards for generic products in non-ICH countries, and intensify its efforts to develop international standards and guidelines for the regulatory assessment of generic products. WHO should offer specific advice to national authorities in non-ICH countries.
5. Progress should be reported back to the ICDRA.