WHO target product profiles
A target product profile (TPP) outlines the desired ‘profile’ or characteristics of a target product that is aimed at a particular disease or diseases. TPPs state intended use, target populations and other
desired attributes of products, including safety and efficacy-related characteristics. Such profiles can guide product research and development (R&D):
In the context of
public health, TPPs set R&D targets for funders and developers.
Over the last decade public health-oriented funders have increasingly developed their own TPPs. It is not always clear how these TPPs
relate to WHO’s preferences, creating the possibility that not-for-profit product development programmes are not always well aligned with WHO’s identified needs.
WHO TPPs support the development of missing health products, keeping
focus on public health priorities. WHO TPPs recognize that access, equity and affordability are integral parts of the innovation process and need to be considered at all stages, not just after a product is developed.
Features of a WHO TPP document
The WHO TPP documents aim to inform product developers, regulatory agencies, procurement agencies and funders on R&D and public health priorities. They describe (1) the preferred and (2) the minimally acceptable profiles for vaccines, therapeutics,
diagnostics or medical devices criteria. They also provide information for funders and developers on the performance and operational characteristics expected of products if they are to meet WHO’s needs.
Where WHO has identified a priority
need for a product class but the stage of development is early, ‘preferred product characteristics’ (PPCs) might be provided; while generally specifying WHO’s preferences these do not specify minimally acceptable criteria.
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