What is a Target Product Profile?

The World Health Organization (WHO) defines a target product profile (TPP) as the “desired profile or characteristics of a target product that is aimed at a particular disease/disease”. A TPP states the intended use of the product, what the target population would be, and other characteristics of the product that are deemed desirable for treating the particular disease (including attributes related to safety and efficacy). This information helps in guiding research and development (R&D) of the product towards desired characteristics.

What is the importance of a target product profile in the regulatory context?

A TPP can be considered a tool to help frame development in relation to the submission of product dossiers. It sets the criteria based on which clinical trials, safety studies, and quality testing for the product are conducted. This alignment ensures that the risk of regulatory delays and non-compliance is mitigated as the TPP ensures that all the data collected is relevant to the product’s approval. The TPP acts like a regulatory roadmap for the entire drug development process and brings together complex, multi-stage development processes, and increases the likelihood of successful dossier submission.

How does a WHO TPP ensure comprehensive support for product development?

A WHO TPP ensures that the development of the missing health product is comprehensively supported while focusing on priorities of public health. A WHO TPP highlights integral parts of innovation such as access, equity, and affordability, and that these aspects need to be considered throughout all product development stages.

A WHO TPP document informs regulatory agencies on the product’s R&D and public health priorities. It describes the preferred and minimally acceptable profiles for medicinal products including vaccines, diagnostics, and/or medical devices.

If WHO identifies a priority need for a product, but the development stage is relatively nascent, a “preferred product characteristic” (PPC) may be provided.

DDReg’s Capabilities

DDReg offers comprehensive regulatory expertise in developing and aligning target product profiles (TPPs) with global standards, such as those of WHO. The team has a deep understanding of regulatory requirements and experience in strategic dossier planning.