Prequalification Reports

Transparency is a key principle of WHO prequalification. The need for such transparency was underscored by World Health Assembly Resolution WHA57.14, of 2004.

The Resolution requested WHO’s Director-General:

to ensure that the prequalification review process and the results of inspection and assessment of the listed products, aside from proprietary and confidential information, are publicly available.

WHO therefore posts on this website:

A WHOPAR is made available following prequalification of the product concerned. A WHOPIR is made available following inspection of a manufacturing site, contract research organization or quality control laboratory, and that has demonstrated compliance with the relevant good practices.

Additional important outputs of WHO prequalification, of particular value to regulators and procurers are:

These outputs, as well as the standards and procedures that underpin WHO medicines prequalification, can also be accessed on this website.