Development of a Regional Guideline for the Eastern Mediterranean Region

Abstract

The World Health Organization/Eastern Mediterranean Regional (WHO/EMR) Office has organized a consultation on “Regional Guidelines on Stability Studies of Medicines and Biologicals” on February 25–28, 2006, in Jeddah, Saudi Arabia. The meeting was attended by participants from 12 countries from the region. The objectives of this consultation were to: (a) review national requirements for stability studies of medicines and biologicals; (b) update participants with recent advances in the area of stability studies of medicines and biologicals; and (c) develop regional guidelines on stability studies of medicines and biologicals. In September 2006, the WHO/EMRO Regional Committee adopted the regional guidelines on stability testing of active substances and pharmaceutical products after the inclusion of comments made by the member states as appropriate and requested member states to revise the requirements for drug registration to be consistent with these guidelines. The proposed guidelines constitute the basis for the revision of the Global WHO Stability Guidelines. Several other recommendations were also passed to emphasize the need to strengthen national expertise in this area and to carry out post-marketing studies to ensure drug stability throughout the distribution channel and the recommended shelf-life.