Summary – Description
The WHO prequalification of medicines was established in 2001 to ensure quality, safety and efficacy of medicines and health products procured by the UN Agencies, and other international procurement agencies. To date, more than 500 products for HIV/AIDS, tuberculosis and malaria, childhood diarrhoea and for reproductive health have been prequalified, supporting several billions of US dollars’ worth of medicines supplied to low- and middle-income countries (LMIC). However, prequalified products must still be granted marketing authorizations or registration by the national medicines regulatory authorities (NMRAs) of the countries for which market entry is sought. Therefore, to avoid duplication of work by NMRAs, and to enable faster registration of prequalified products, WHO introduced the collaborative procedure in 2012. To date, more than 30 countries are officially participating and more than 180 products have been registered by NMRAs through this collaborative procedure.
Join us for a session focused on the steps of the procedure, roles of different players, and practical advice that will give you the essential information to use or recommend this procedure to support either national registration of prequalified products, overcome the obstacles at national level in registering prequalified products and to support procurement decisions.
What you will learn:
- How the collaborative procedure works and facilitates national registrations
- How the procedure ensures the national registration of products as was prequalified in all aspects as was assessed by WHO from the site(s) inspected by WHO
- Other collaborative mechanisms that are being supported by the WHO to accelerate access to quality, safe and efficacious medicines
About the presenter
Dr. Luther Gwaza is a pharmacist with a PhD from Utrecht University in Pharmaceutical Policy and Regulation. Luther has more than 8 years’ unique experience, first as a senior assessor in the WHO PQT-medicines (prequalification team) and second, as a national regulator working NMRA in Zimbabwe for more than 8 years (user of prequalification outcomes). Currently, he is a Technical Officer responsible for the collaborative procedure in WHO based in Geneva. In addition, Luther has extensive knowledge and experience in the regulation of medicines, vaccines and other health products at a national and international level. He has consulted for various international organizations such as World Bank, WHO, Management Sciences for Health (MSH), and International Finance Cooperation (IFC), on systems strengthening, harmonization, collaboration and cooperation in medicines regulation in Africa and Asia.