This pilot initiative aims to enhance the quality assurance and accessibility of NTD diagnostic tools for health-care providers
The World Health Organization (WHO) has introduced a pilot scheme for a WHO Expert Review Panel for Diagnostic Products (ERPD) for NTDs. This pilot initiative aims to enhance the quality assurance and accessibility of NTD diagnostic tools for health-care providers.
The landscape of in-vitro diagnostics (IVDs) is rapidly evolving, posing significant challenges to procurers, health-care programmes, and authorities for public health and patient care. Notably, in the field of NTD diagnostics, challenges are multiple. Low profit margins and limited returns on investment make the NTD diagnostics market unattractive to manufacturers and suppliers, resulting in uncertainty about the quality of many NTD diagnostic products. Additionally, the revision of regulatory frameworks all over the world and in western countries for IVDs, associated with expensive procedures, has disrupted the availability of some NTD diagnostics.
While solutions are being proposed to manufacturers, regulatory bodies and health-care programmes to make the best choices for procurement of quality-assured, safe and performant IVDs for the benefit of public health through WHOs IVD prequalification programme (WHO PQ), they are not appropriate for all categories of IVDs.
Currently, NTD diagnostics do not fall within the scope of WHO prequalification. To address this issue, WHO PQ is introducing the ERPD pilot scheme for NTDs. This new ERPD is intended to fill the critical need for NTD diagnostic tools by providing independent expert advice on specific categories of IVDs. The ERPD is an independent advisory body of technical experts, coordinated by the WHO PQ team to assess the risks and benefits associated with non-prequalified IVDs, for specific intended use, within specific settings and that may have a significant public health impact, like NTD diagnostics. This programme represents a significant step towards ensuring that NTD diagnostics meet international quality standards. It will provide procurers, donors and national disease control programmes with advice to aid procurement decisions for candidate products.
The proposed ERPD for NTDs will be coordinated by the WHO PQ team in close collaboration with the Global NTD Programme, reaffirming WHO’s dedication to tackling NTDs and enhancing global health equity and patient care.