Capacity Building

WHO medicines prequalification is in a unique position given its in-depth experience of assessing finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs) across a range of therapeutic areas. Experience in prequalifying quality control laboratories (QCLs) has also proved invaluable when working with countries to increase their capacity to monitor the quality of medicines circulating on their markets.

Hands-on training for regulators

WHO passes on its experience in assessing FPPs and APIs to regulators through hands-on training. This includes opportunities for:

  • participation in assessment sessions or in the annual prequalification assessment training, held at UN City, in Copenhagen, Denmark
  • rotational fellowships at WHO Headquarters in Geneva, Switzerland for assessors of low- or middle-income countries
  • participation in the WHO Collaborative Procedure for Accelerated Registration
  • participation in hands-on assessment training organized by individual national regulatory authorities or by regulatory networks.

The training offered benefits not only regulators but also WHO prequalification since the regulators trained bring their own insights into regulatory issues and the problems that may be faced by manufacturers or QCLs when seeking to attain prequalification. And on returning to their own countries, they continue to promote and support WHO prequalification.

Regulators working with a national medicines regulatory agency who are interested in hands-on training should contact Dr Matthias Stahl if interested in inspection training. Regulators interested in the WHO Collaborative Procedure for Accelerated Registration, or in training organized by national regulatory authorities or by regulatory networks, should contact Dr Luther Gwaza.

Hands-on training for QCL staff

WHO has developed a peer audit system within the network of QCLs involved in WHO prequalification. Through peer audits QCLs can identify gaps in their technical competence and/or activities, and work towards eliminating these. Peer audits also provide training opportunities for QCL auditors. Further information or a request to participate in a mutual audit can be sent to Mr Rutendo Kuwana.

Training workshops for regulators, manufacturers and QCL staff

WHO organizes training workshops for regulators and for manufacturers. Topics are varied but may cover regulatory data requirements, assessment, principles and specific requirements relating to Good Manufacturing Practices, Good Clinical Practices and/or Good Laboratory Practices, WHO’s Collaborative Registration Procedures, pharmaceutical development and WHO prequalification requirements.

Some workshops are organized for a combined audience of regulators and manufacturers since each group can find it informative to better understand the perspectives and challenges in regulation or manufacturing of the other group. Training workshops are generally by invitation only, but workshop PowerPoint presentations are made publicly available on the Events section of this website. (WHO training modules on GMP and QCL topics can also be of great value when seeking to improve staff competencies.)

Provision of feedback and support to manufacturers during prequalification process

During evaluation of an API or FPPs submitted for WHO prequalification a manufacturer may receive valuable guidance that will assist it in quality-assured production of not only the product undergoing evaluation but any other products that it produces. Surveys of manufacturers have indicated that this feedback is highly valued. Feedback may take the form of written communication or one-to-one meetings (held during a Copenhagen assessment session, at WHO Headquarters in Geneva, or during the annual prequalification meeting with manufacturers).

Organization of specialized technical assistance for manufacturers, CROs and QCLs

WHO provides technical assistance to help recipients develop the capacity to achieve compliance with international regulatory norms and standards, so that they can attain WHO prequalification for priority products or services. It is available for:

  • manufacturers who produce or plan to produce priority APIs or FPPs, as listed on current Invitations to Manufacturers to Submit for Product Evaluation
  • CROs that conduct or plan to conduct clinical studies for FPPs listed on current Invitations to Manufacturers to Submit for Product Evaluation
  • national QCLs that conduct or plan to conduct quality control testing for of priority FPPs, as listed on current Invitations to Manufacturers to Submit for Product Evaluation.

view specialized technical assistance >

Medicines prequalification guidance

During the process of prequalification – be these of finished pharmaceutical products, active pharmaceutical ingredients or QCLs – WHO learns which issues are the source of greatest difficulty. One of the ways in which it seeks to provide support to overcome these is by producing prequalification guidance documents. Much of this guidance is developed with feedback from manufacturers and regulators, thereby ensuring its relevance and clarity.

view prequalification guidance >

Dissemination of prequalification information

Additionally, WHO makes Public Assessment Reports, Public Inspection Reports and reports on medicines quality monitoring projects available on this website, and regularly publishes peer-reviewed articles on assessment findings, to further facilitate transfer of medicines knowledge and expertise.