About us

Quality-assured, safe and effective medicines, vaccines and medical devices, including in-vitro diagnostics are fundamental to a functioning health system. But globalized trade can undermine regulation, and in resource-limited settings especially, incidence of substandard or falsified medicines is growing. WHO aids countries to strengthen regulation, including post-marketing surveillance, and to eliminate substandard and falsified medicines. It also develops international norms and standards, so that countries worldwide can regulate health products and technologies consistently. In parallel, WHO facilitates access to quality-assured, safe and effective health products by assessing medicines, vaccines and medical devices for priority diseases.

Helping NRAs fulfill their mandate in an effective, efficient, predictable and transparent manner is therefore of critical importance in ensuring the quality, safety and efficacy of health products in an increasingly complex global environment.

NRAs perform their mandate based on a legal framework and a set of recommended regulatory functions that span the medical product lifecycle including clinical trial oversight, marketing authorisation and registration, licensing and inspection of premises, market surveillance and enforcement activities when required.

• The assessment of regulatory functions using a standardized tool and the creation of an institutional development plan (IDP) designed to bring each NRA up to benchmarked international standards.
• Direct technical assistance based on country IDPs.
• Support for information and work-sharing arrangements made possible through the implementation of harmonized standards and best practices and the creation of regional and global regulatory networks.

WHO Prequalification aims to ensure medicines, vaccines and other health products for supply to low-income countries are quality-assured, safe, effective and accessible to all populations.

Ensuring access to safe, effective and quality health products for all is a cornerstone of universal health coverage, one of WHO’s top priorities and the foundation of Sustainable Development Goal 3 (“Ensure healthy lives and promote wellbeing for all at all ages”).

WHO Prequalification concentrates its activities on high-priority therapeutic areas in low- and middle-income countries. For medicines, it includes HIV/AIDS, malaria, tuberculosis, hepatitis C, tropical diseases and reproductive health; key childhood diseases for vaccines, such as polio, typhoid, rotavirus and yellow fever; HIV/AIDS, hepatitis and cholera for diagnostics; and malaria and other mosquito-borne conditions for vector control products.

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