This introductory workshop was the sixth in a series of introductory workshops undertaken by WHO Regional Office for the Eastern Mediterranean to promote the WHO prequalification programme for priority medicines in the Region. Previous workshops were conducted in countries with a sizable pharmaceutical industry – Egypt, Jordan, Islamic Republic of Iran, Pakistan and Syrian Arab Republic.
The workshop provided essential information for manufacturers and regulators from the Region on the process of joining the WHO prequalification programme for priority essential medicines. It also allowed a training opportunity on dossier preparation and GMP regulations for inspection, which contributes to increasing capacity of participating national medicines regulatory authorities officials.
The workshop brought together participants from countries of the Gulf Cooperation Council, Libya and the occupied Palestinian territory, in addition to some selected manufacturers from Egypt, Jordan and Morocco who have already started in the process of dossier submission. Participants include representatives from pharmaceutical manufacturer’s and medicines regulatory agencies from these countries, in addition to selected manufacturers from other countries in the Region.
The WHO prequalification programme is a voluntary programme in which manufacturers of selected medicines can apply for an assessment and inspection process in which accepted applications will be added to a WHO list of prequalified medicines. Prequalified medicines can then be used by international agencies such as the Global Fund, UNICEF, World Bank, Medecines Sans Frontieres for bulk purchase orders. The programme has operated at a global level since 2001 and is currently limited to medicines for tuberculosis, malaria and HIV/AIDS, in addition to some selected medicines for reproductive and child health and influenza. Although the Eastern Mediterranean Region includes countries with a sizable pharmaceutical industry, only one anti-malarial product has been pre-qualified from Morocco from the 245 medicines currently listed.
