The WHO PQ Collaborative Procedure for Accelerated Registration


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 diarrhea 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.

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