(2003; 148 pages)
2.6 Future of The International Pharmacopoeia
The Committee was informed of the new WHO strategy for a global step-wise approach to the quality control of pharmaceuticals, including basic tests, screening tests, and monographs in The International Pharmacopoeia. The development of new monographs for The International Pharmacopoeia would give priority to the needs of specific disease programmes and the essential drugs nominated under these programmes.
The Committee confirmed that The International Pharmacopoeia continued to fulfil a need in developing countries. While it contains monographs with stringent specifications, it also provides equally acceptable but less technically demanding alternative methods for specific substances and preparations wherever possible.
At an informal consultation held in Geneva on September 2001, the uniqueness of WHO’s role in developing global standards was emphasized and the global and step-wise approach to the quality control of pharmaceuticals and the list of priorities given in this document were strongly supported.
The following recommendations were made by the Expert Committee:
• In the light of the increasing shift to more sophisticated methods and international proposals to introduce more stringent test limits, The International Pharmacopoeia and related activities should be strengthened and promoted.
• The approach recently adopted whereby alternative test specifications are included in new monographs for The International Pharmacopoeia should be maintained.
• The title of The International Pharmacopoeia should be maintained.
The Committee adopted the recommendations and the relevant document entitled “The International Pharmacopoeia: revised concepts and future perspectives” (Annex 2). The Committee also agreed that the survey of the use of The International Pharmacopoeia conducted 5 years ago should be repeated, and advocated that The International Pharmacopoeia should be promoted more effectively.