Our work

Horizon Scanning and landscape assessment: used to assess the health product and technology landscape and collate information on global health research in order to enhance, optimize and prioritize research agendas. Current resources include the Global Observatory on Health Research and Development which tracks and analyses health R&D around the world and the International Clinical Trials Registry Platform which collates ongoing trials worldwide to ensure transparency of research.

Support for the development of target product profiles (TPP): TPPs outline the desired attributes and characteristics of health products for a specific disease or condition such as target population, intended use or indication. TPPs guide research and development activities by product developers allowing them to better fulfill requirements for regulatory pathways including WHO prequalification and for WHO policy recommendations. TPPs promote R&D that will result in products with a higher public health value.

Learn more about TPPs here.

Guidance on evidence generation: While TPPs provide high level guidance on endpoints and target populations, these are not sufficiently granular to enable the design of clinical trials or studies that fit requirements for regulatory authorities, WHO prequalification or policy recommendations. WHO develops methodological guidance based on a consultative process involving scientific, regulatory, public health, end user and implementation expertise to support better trial design. The objective is to decrease timelines by avoiding the need for additional studies to be conducted later in the development pathway.

Coordinated Scientific Advice for health product R&D: To expedite development of health products (including novel therapeutics, diagnostics, vaccines, vector control products and repurposing or reformulating products) WHO provides an advice process whereby product developers may approach WHO and obtain joint advice from WHO Prequalification and the relevant WHO technical department(s), if the product meets criteria for public health value. The aim of the procedure is to ensure submissions for WHO prequalification assessment or for a policy recommendation meet WHO requirements and thus accelerate timelines to listing and uptake. Find out more about the Coordinated Scientific Advice procedure here.

Coordination between prequalification and development of policy recommendations: In order to avoid a delay in availability of policy recommendations and/or related prequalified products, the WHO Science Division ensures coordination between prequalification and the development of policy recommendations through early discussions of products likely to proceed through prequalification assessment. This includes coordination with regulators likely to form the basis of first licensure of the product to identify potential regulatory issues and bottlenecks and prepare for regulatory approval. The aim is to decrease the time between product dossier availability, prequalification and in some cases, country registration.

Implementation Research: Research performed to prepare for optimal introduction of new health products can identify potential issues and solutions before widespread roll-out of new products. It is a systematic and early approach to assessing barriers to uptake and interventions to address the barriers identified. WHO provides advice on best practice for implementation research, including advice on best practice monitoring and evaluation and safety surveillance during roll-out. The aim of this process is to reduce time to implementation by ensuring all research is of the highest quality, reducing the time taken to refine proposals or projects, and increasing the speed of implementation as roadblocks have been identified prior to implementation.