Safe Diagnostics: World Health Orangization (WHO) Leads the Way
Introduction
The World Health Organization (WHO) is a specialized agency of the United Nations for public health, based in Geneva. It was founded on 7 April 1948 and has 194 member states. According to the WHO constitution, its goal is to achieve the best possible level of health for all people. The focus is primarily on combating infectious diseases.
WHO prequalification programme
The WHO coordinates a so-called prequalification programme for essential medicines and health products.
The goal of the WHO prequalification of in vitro diagnostic medical devices (IVDs) is to promote and facilitate access to safe, efficient and affordable IVDs in an equitable manner. The focus is on IVDs for use in resource-limited areas that aid the diagnosis of common, serious diseases. The program involves comprehensive assessment of individual IVDs through a standardized procedure aligned with established international regulatory practices. Products that have completed the program may be procured by United Nations organizations for use in low-income countries
Technical Guidelines
As part of implementation of the programme, the WHO has established technical guides for manufacturers seeking to qualify their products. It is good to know that the European Medical Device Coordination Group guideline MDCG 2022-2 directly references definitions from TGS-8 guideline regarding certified reference materials and methods. (Technical Guidance Series (TGS) for WHO Prequalification – Diagnostic Assessment TSG 8 - Quality control for in vitro diagnostic medical devices for WHO prequalification.)
Updates (April 2024)
In April 2024 there was an updated admission criteria for WHO prequalification of IVDs: Previously limited to critical pathogens (Hepatitis B and C virus, Malaria parasites, Treponema pallidum, Human Papillomavirus, SARS-CoV-2) it now includes diabetes markers blood glucose and HbA1c. Information and forms are available on the WHO website.
Abbreviated Assessment
There you will also find information about a shortened qualification procedure ("Abridged Assessment") available for IVDs that have already achieved some form of approval. While successful WHO prequalification does not indicate conformity with EU regulations, WHO technical guidelines can provide helpful information for performance evaluation of new IVDs. WHO qualified devices may be also used as a reference.
International Standard Preparations
The WHO also evaluates International Standard Preparations which are provided by Medicines & Healthcare products Regulatory Agency (NIBSC). They support standardization of diagnostics and medical products.
For example, international standard preparations targeting SARS-CoV-2-associated diagnostics have been continuously evaluated and made available in the years 2020 to date. These include the first international standard for SARS-CoV-2 RNA (20/146), but also serological reference panel for SARS-CoV-2 variants (1st WHO Reference Panel for anti-SARS-CoV-2 variants, immunoglobulin).
One focus of the WHO standard preparations is to aid the diagnostics of emerging diseases. For example, a number of Lassa virus RNA preparations were made available in 2022, but also preparations for diagnostics targeting monkeypox virus infection. In December 2024, the first International Standard for Antibody Determination in relation to the Marburg Virus was added to the program. An overview of new standards and reference materials is available on the corresponding NIBSC website.
Conclusion
- WHO programs aim to improve healthcare for the global population
- IVD manufacturers benefit from WHO resources through technical guidelines
- IVD manufacturers may significantly contribute to global healthcare
- WHO International Standard Preparations are valuable reagents serving as reference preparations for metrological traceability, significantly contributing to harmonization and comparability of IVD analytical performance data
Act Now: Ensure Diagnostic Quality with WHO Support!
The WHO supports global access to safe and effective IVDs through its prequalification program and international reference materials.
Take advantage of WHO guidelines and streamlined procedures to strengthen your product's impact and visibility.
Contact us – we're happy to support you!
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