Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

The Laboratory Networks and Services (LNS) team within the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department, is tasked with enhancing the REG Unit’s end to end strengthening of regulatory systems by facilitating and promoting access to laboratories meeting international and/or WHO norms and standards.

LNS therefore engages in the following activities across various medical product streams, including diagnostics, medicines and vaccines;

  • Assessing compliance of laboratories with required standards e.g. WHO Norms and Standards, WHO Prequalification and Benchmarking.
  • Assisting national laboratories to achieve technical maturity and/or prequalification through direct technical assistance or other collaborations including audits.
  • Building and supporting regional and global collaboration and networks of laboratories.
  • Organizing and coordinating laboratory testing as dictated by various needs (e.g. pre/post prequalification, following complaints, quality surveys, support of national regulatory approvals, development of WHO standards and guidelines, resolution of ad hoc issues related to quality.).
  • Initiation and performance of trainings, feasibility, collaborative and proficiency testing studies.

As such LNS provides support to a wide range of teams, units and departments across the organization.

person holding medicine bottle
LNS support to WHO Prequalification of health products The objective is to improve and/or maintain the quality of laboratory testing of health products used for regulatory purposes and to increase the range of quality control laboratories for which the acceptability for use by United Nations agencies has been proven. LNS coordinates the prequalification of the quality control laboratory (QCL) for medicines. This activity includes advocacy for prequalification of QCLs and technical support in particular for national QCLs to achieve prequalification. In addition, LNS contributes to safeguarding and facilitating access to WHO prequalified medicinal products. LNS achieves this through collection and analysis of data from Official Batch Release (OBR) results, coordination of independent testing by WHO contracted national control laboratories and verification of quality to support PQ decisions for new applications LNS maintains a portfolio of WHO contract laboratories globally by performing regular audits to ensure that international standards for safety, quality and performance are met for conduct of physical testing on vaccines on behalf of WHO.
Prequal - Quality Control Laboratories

Laboratories play an important role in ensuring that health systems have the capacity to measure and monitor the quality of health products on the market. As such QC laboratories need to be regular and able to support a consistently resilient system that is pragmatically responsive to emergencies and high risk of substandard and falsified medical products entering the supply chain. LNS, in collaboration with other RPQ teams, provides guidance and assessment towards qualification of those laboratories that will be used for pre- and post-approval testing of medical products and provide post market surveillance testing of prequalified vaccines.

Supporting regulatory benchmarking of national QCLs

LNS, on request, supports the Regulatory Systems Strengthening (RSS) team in conducting benchmarking as well as implementation of the corrective actions and monitoring of progress for laboratories.

Publications

Report of the sixth general meeting of the WHO national control laboratory network for biologicals, Cairo, Egypt, 26-28 November 2024

The sixth general meeting of the World Health Organization – National Control Laboratory Network for Biologicals (WHO-NNB) was held in Cairo, Egypt,...

WHO Global Network of National Quality Control Laboratories for Pharmaceuticals: first meeting report, Rio de Janeiro, Brazil, 1-3 October 2024 

The first annual meeting of the World Health Organization (WHO) Global Network of Quality Control Laboratories for Pharmaceuticals (WHO-GNP) was organized...

Report of the fifth general meeting of the WHO national control laboratory network for biologicals, Bangkok Sukhumvit, Thailand, 13-15 December 2023

This is the meeting report of the fifth general meeting of the World Health Organization – National Control Laboratory Network for Biologicals (WHO-NNB),...