NEW YORK – The World Health Organization on Tuesday introduced a pilot initiative creating an Expert Review Panel for Diagnostic Products, or ERPD, for neglected tropical diseases. The goal of the initiative is to enhance quality assurance and accessibility of NTD diagnostics, WHO said in a statement.
"This program represents a significant step towards ensuring that NTD diagnostics meet international quality standards," WHO said. Specifically, the ERPD will advise procurers, donors, and national disease control programs on procurement decisions for candidate products.
These groups are frequently challenged by the uncertain quality of NTD diagnostics, WHO said, while low profit margins and restricted return on investment makes the NTD market less attractive to diagnostics developers. Availability of NTD diagnostics has also been disrupted by revised IVD regulatory frameworks worldwide.
Because NTD diagnostics do not currently fall within the scope of WHO's IVD prequalification (PQ) program, the WHO PQ team is introducing the ERPD pilot scheme for neglected tropical diseases to fill the critical need for NTD diagnostic tools.
The ERPD will provide independent expert advice on specific categories of IVDs and will be coordinated by the WHO PQ team in collaboration with the Global NTD Programme, WHO said. The panel's experts will assess the risks and benefits associated with non-prequalified IVDs for specific intended uses, within specific settings, and that may have a significant public health impact.
The proposed ERPD for NTDs will be coordinated by the WHO PQ team in close collaboration with the Global NTD Programme.