History

  WHO medicines prequalification was first established in 2001, in response to the HIV/AIDS pandemic. Its aim was to guide UN agencies and other international organizations with respect to the quality of antiretroviral medicines, for supply to low-income countries. Following the success of WHO medicines prequalification in increasing access to treatment for HIV/AIDS, its scope has been gradually expanded to cover additional therapeutic areas. 

Most recently, pilot prequalification of biotherapeutic medicines for treating cancer and of insulin for treating diabetes has been initiated, ushering in a whole new area of application for medicines assessment and inspection expertise. Further expansion of medicines prequalification to products ‒ be these chemical entities or biotherapeutic products ‒ for treatment of additional non-communicable diseases is anticipated.

Vision and mission

The vision of WHO medicines prequalification is simple: good quality medicines for everyone. Its 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.

Strategy

WHO's strategy for achieving this 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, 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.

Key outputs

The outputs of WHO medicines prequalification 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.