Target Product Profiles, preferred product characteristics and target regimen profiles

WHO product profiles are a planning tool to guide health product research and development (R&D). They specify the intended use, target populations, and desired attributes of products; support evidence generation for regulatory submissions; and help create alignment on R&D targets and priorities for funders and developers.

WHO product profiles have particular requirements and specific objectives:

• Enabling developers and funders to align their product pipeline with public health priorities
• Integrating implementation and end-user needs and considerations into product R&D phases with a specific focus on the most vulnerable populations
• Demonstrating likelihood of policy development and thus product purchasing
• De-risking investment in health product R&D
• Supporting ethical R&D for product development
• Facilitating ease of product review and accelerating guideline development

1. Preferred product characteristics (PPCs):
   • Applicable to product classes of priority with a pipeline in early development
   • Provide strategic guidance and higher-level considerations
   • Specify WHO preferences but not minimum acceptable criteria
2. Target product profiles (TPPs):
   • Describe optimal characteristics for health product
   • Include minimal essential characteristics for product usability
3. Target regimen profiles (TRPs):
   • Applicable to certain disease areas (e.g., tuberculosis) requiring multiple therapeutics to be combined into treatment regimens.

    

WHO product profiles describe the (a) preferred and (b) minimally acceptable profiles for vaccines, other preventive methods such as vector control, therapeutics, diagnostics or medical devices. The broad sections of TPP and PPC documents are as follows:

1. Overview:
   • Background and specified purpose statement
   • Rationale for the document
2. Methods:
   • Describe process used for product profile development
3. Profile (some compulsory headings) and clarifying text as needed.
   • TPPs contain minimal and optimal characteristics; PPCs should not contain minimal acceptable criteria
4. Supporting narrative sections

In some cases, an external TPP may be adapted and redeveloped into a WHO-compliant TPP. A specific pathway is available for these products.

Target product profile directory