The recent Lancet Commission on Diagnostics found that nearly 50% of the global population have little to no access to diagnostics. In vitro diagnostic assays (IVDs) are essential tools across a number of communicable and non-communicable diseases, both across programmes as well as during emergency outbreak response.
WHO has developed a number of supportive and relevant documents, such as target product profiles (TPPs), Prequalification (PQ) technical specifications and procurement specifications. However, specific elements or guidance on designing and developing an IVD for low- and middle-income countries (LMIC), and their particular challenges, is often scattered across various documents or has become part of a disease-specific TPP. The lack of a clear and comprehensive guidance document oftentimes results in manufacturers relying on their proven development and market strategies and/or product design, leaving procuring countries to try to adapt their storage and supply chain managements to the products available in developed settings.
Thus, the purpose of this draft TPP is to provide considerations and preferred characteristics for manufacturers to proactively develop or adapt their IVDs to LMIC markets.
This proposed document should be seen as a disease non-specific target product profile, with a list of generic characteristics that will affect the reliability and thereby the access of IVDs in LMIC settings, helping to improve procurement processes by easing the selection and distribution of IVDs, particularly in resource-limited settings.
The World Health Organization is now seeking feedback on this draft TPP from experts in industry, product developers, the scientific community, implementers and health programme personnel involved at any stage of the IVD product cycle.
Comments may be submitted by individuals or organizations and will be accepted until Monday 1 September 2025, using the following feedback form: