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.

More information can be found on the following links:
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.
Technical Units
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