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Problems with the quality of medicines and their supply led to the creation of WHO medicines prequalification in 2001. From a public health perspective, the greatest achievement of medicines prequalification has been to improve the quality of life-saving medicines used today by millions of people in low- and middle-income countries. Indeed, medicines prequalification has made it possible to believe that everyone in the world will have access to safe, effective, and affordable medicines.

Perhaps most importantly, it has demonstrated and continues to demonstrate that the production, supply and regulation of quality-assured medicines is a shared endeavour between regulators, manufacturers, procurers, health providers, donors and WHO. The efforts of each of these stakeholders is essential to increasing universal health coverage, protecting people from health emergencies and providing people with better health and well-being.

Key activities and standards applied

Medicines key prequalification activities are:

  • assessment of product dossiers (for finished pharmaceutical products (FPPs) or master files (for active pharmaceutical ingredients (APIs)
  • inspection of manufacturing and clinical sites
  • organization of quality control testing of products.

WHO also prequalifies quality control laboratories (QCLs), specifically those QCLs that carry out chemical and microbiological testing of medicines. 

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.

On this website...

Here in the medicines part of the WHO prequalification website you can find:

  • key prequalification outputs: the lists of prequalified FPPs, APIs and QCLs, and WHO Public Assessment Reports and WHO Public Inspection Reports
  • detailed information about submission of FPPs and APIs products for prequalification and how to obtain QCL prequalification
  • links to considerable prequalification and other WHO guidance: relevant not only to manufacturers seeking prequalification but also to all manufacturers who wish to ensure quality-assured production of their FPPs and/or APIs, and to medicines regulators
  • information about medicines evaluation pathways other than prequalification
  • an overview of market information that can help manufacturers make decisions regarding submission for prequalification.