WHO Prequalification

About WHO Prequalification

The WHO Prequalification program ensures that vaccines purchased by UN agencies meet international standards of quality, safety, and efficacy. The program was established in 1987 for vaccines and expanded to medicines in 2001. UN agencies such as UNICEF generally procure only prequalified vaccines. The prequalification process involves review of clinical data, manufacturing site inspection, and laboratory testing. Stringent Regulatory Authority approval, such as from the FDA or EMA, can expedite prequalification. The prequalification program has been particularly important for vaccines manufactured in India, China, and other emerging producers. The Serum Institute of India, the worlds largest vaccine manufacturer by volume, has multiple WHO prequalified vaccines. The program ensures that vaccines used in developing countries meet the same quality standards as those used in wealthy countries.