What We Do

We prequalify FPPs, APIs and QCLs

WHO medicines prequalification ensures that active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) are safe, appropriate and meet stringent quality standards. The principal medicines prequalification activities are: assessment of product dossiers (for FPPs) or master files (for APIs); inspection of manufacturing and clinical sites; and organization of quality control testing of products. These activities form part of WHO's broad access agenda which seeks to expand access to quality-assured medicines. In addition to medicines, WHO prequalification also covers immunization devicesin vitro diagnostics, vaccines and vector control products.

APIs that meet assessment and inspection criteria are added to the WHO List of Prequalified Active Pharmaceutical Ingredients. FPPs that meet assessment and inspection criteria are added to the WHO List of Prequalified Medicinal Products.

WHO also prequalifies quality control laboratories (QCLs), specifically those QCLs that carry out chemical and microbiological testing of medicines. QCLs whose analytical activities are found to comply with the standards recommended by WHO are added to the WHO List of Prequalified Quality Control Laboratories.

The standards used to evaluate FPPs and APIs, and their manufacturing sites, are based on the principles and practices agreed by the world’s leading regulatory agencies and adopted by the WHO Expert Committee on Specification for Pharmaceutical Preparations.

Other medicines prequalification activities include:

  • training (for manufacturers, regulators and QCLs)
  • provision of technical assistance (for manufacturers and QCLs)
  • implementation of the collaborative procedure for registration.

Assessment

Information submitted in support of  finished pharmaceutical products (FPPs) or active pharmaceutical ingredients (APIs) is assessed to determine whether these products meet the requirements and standards for WHO prequalification. The master file (MF) of an API may be assessed either because it is linked to an FPP, or because the API itself has been submitted for prequalification.

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Capacity Building

The immediate aim of WHO medicines prequalification is to increase the availability of quality-assured medicines and of proficient medicines testing. In the immediate- to longer-term it aims to build the capacity of countries to produce and regulate quality-assured medicines. It therefore carries out many activities that help manufacturers, contract research organizations (CROs) regulators and medicines quality control laboratories (QCLs) to enhance their respective skills and expertise. All of these activities benefit from the rich experience gained by medicines prequalification staff during the past 15 years.

How is capacity built?

Capacity is built through:

  • hands-on training for regulators, including participation in the Collaborative procedure for Accelerated Registration
  • hands-on training for QCL staff
  • organization of training workshops for regulators, QCL staff and regulators
  • provision of feedback and support to manufacturers during evaluation for prequalification
  • organization of technical assistance for manufacturers, CROs and QCLs
  • issuing of medicines prequalification guidance for consultation by manufacturers, regulators and QCLs
  • dissemination of prequalification information.

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Our key outputs

The key outputs for WHO medicines prequalification are: