The Regulation and Safety unit, through the LNS team, hosts global networks for National Laboratories supporting prequalification and national regulatory authorities to ensure the quality of medicines and vaccines pre and post market.
The main objectives of the laboratory networks are to:
- Share quality and technical information and activities to optimize the use of expertise and laboratory resources.
- Facilitate reliance and/or recognition of testing data amongst QCLs.
- Promote and contribute to the development of harmonized common standards and best practice in quality control of medicines, vaccines and in-vitro diagnostics, including provision of input to future development / revisions of WHO guidelines and other international norms and standards of common interest.
- Support capacity building and strengthening of the NRAs and OMCLs in the Network.
WHO Global Network of National Quality Control Laboratories for Pharmaceuticals (WHO-GNP)
The mission of this network is to support the strengthening of regulatory systems for medicines by enhancing the technical capacity and competence of national quality control laboratories for pharmaceuticals. It aims to promote reliance and information sharing, facilitate pragmatic use of resources and access to state-of-the-art technology, and support the WHO Prequalification of Pharmaceutical Quality Control Laboratories (QCL) program through a robust global regulatory network. This network is an informal WHO network; it is not a separate legal entity and derives its legal status from WHO. Therefore, it is administered within WHO and in accordance with WHO policies.
The WHO-GNP envisions a global network of National Quality Control Laboratories for Pharmaceuticals (NQCLs) that supports WHO Member States by ensuring effective monitoring of pharmaceutical quality in their markets. The goal of the WHO-GNP is to serve as a platform that enhances the technical capacity of its members, promotes reliance, contributes to the harmonization of standards and best practices in pharmaceutical quality control, and facilitates the pragmatic use of resources and information exchange.
To achieve these goals, the WHO-GNP will undertake activities aimed at:
- Sharing quality and technical information to optimize the use of expertise and laboratory resources.
- Facilitating reliance and/or recognition of testing data among NQCLs.
- Promoting and contributing to the development of harmonized standards and best practices in the quality control of medicines, including providing input, as appropriate, to the future development or revision of WHO guidelines and other international norms and standards of common interest.
- Supporting capacity building and strengthening of NQCLs within the network through technical assistance, training, and technical audits.
