The World Health Organization in partnership with the UAE Ministry of Health is organizing a three days workshop introducing the WHO prequalification program to manufacturers from the Gulf Cooperation Council states in addition to some selected manufacturers from Egypt, Jordan, Libya, Morocco and Palestine.
Focusing on building regulators’ capacity in the areas of Good Manufacturing Practice, bioequivalence, dossier review, global trends and practices in international bulk procurement, the workshop will assist participating manufacturers to open new markets for export and bulk procurement in international tenders.
The WHO prequalification programme was launched in 2001, driven by global public health needs, to achieve universal access to quality priority medicines, especially for those in need. The programme strives to achieve its vision through close collaboration with national medicines regulatory authorities, manufacturers of priority essential medicines and partner organizations.
Prequalification was originally intended to give UN procurement agencies, such as UNICEF, World Bank and a range of other international organizations, those involved in procurement and access to essential medicines, a safe and effective reservoir from which procurement of a range of quality medicines is ensured.
It is worth mentioning that a number of countries in the Region have producers who meet internationally accredited quality levels and standards, and who export medicines to ICH (International Conference for Harmonization) markets and who therefore have good prospects for prequalification of their products. However, of the 337 priority medicines currently on the WHO prequalified list, only one product, amodiaquine-artesunate tablets produced in Morocco, is among those on the list.
This workshop is one in a series of meetings gearing attention towards a very important United Nations interagency collaborative programme that is managed by WHO, namely the WHO prequalification programme for medicines. The programme is operative at global level as a joint United Nations-WHO-UNICEF initiative. The program currently covers medicines for tuberculosis, malaria and HIV/AIDS, in addition to some selected reproductive health medicines, child medicines and influenza-specific antivirals.
In essence, this is a voluntary programme to which manufacturers of these medicines can apply for prequalification. They will receive free evaluation through dossier review, facility inspection and a thorough testing procedure. If these rigorous evaluations conclude that the medicine product and the manufacturing system are up to the WHO quality standards, that specific product is considered prequalified and is automatically added to the WHO list of prequalified medicines. International agencies like the Global Fund, UNICEF, Médecins Sans Frontières, etc. can procure from this list these for bulk purchase orders.