UNAIDS, UNICEF, UNFPA and the World Bank ― and many other organizations ― consider WHO medicines prequalification to be a concrete contribution to the United Nations priority goal of addressing high-burden diseases in countries with limited access to quality medicines.
PQTm’s vision is simple: good quality medicines for everyone.
PQTm’s mission is to work in close cooperation with national regulatory agencies and partner organizations to make quality priority medicines available for those who urgently need them. This is achieved through assessment and inspection activities, building national capacity for manufacture, regulation and monitoring of medicines, and working with regulators to register those medicines quickly.
PQTm’s strategy for achieving its vision has several components:
- apply unified standards of acceptable quality, safety and efficacy.
- prequalify FPPs based on comprehensive evaluation of their quality, safety and efficacy of FPPs, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites
- prequalify APIs by comprehensively evaluating their quality, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing sites.
- prequalify medicines QCLs by comprehensively evaluating the quality of their chemical and microbiological testing services, based on information submitted by the QCLs, and inspection of the corresponding QCL premises
- build the capacity of staff from national regulatory authorities, QCLs, and from manufacturing or other private companies, to ensure that medicines quality is attained and maintained.
PQTm’s key outputs are the:
- WHO List of Prequalified Finished Pharmaceutical Products
- WHO List of Prequalified Active Pharmaceutical Ingredients
- WHO List of Prequalified Quality Control Laboratories
- WHO Public Assessment Reports
- WHO Public Inspection Reports.
An integrated process
The availability, quality, safety and efficacy of medicines is a major concern of WHO. To ensure that quality pharmaceuticals are available, WHO sets norms and standards, develops guidelines and advises Member States on issues related to quality assurance of medicines for national and international markets. WHO assists countries in building national regulatory capacity through networking, training and information sharing. These activities have been endorsed and supported by Member States through numerous World Health Assembly resolutions. WHO medicines prequalification is an important component of these activities and mandate.
Note: On this website, for the sake of simplicity, reference is often made to WHO, rather than to WHO PQTm, when describing activities undertaken to evaluate products and QCLs for prequalification.