Snapshot

The Coordinated Scientific Advice (CSA) for Health Product R&D pathway has been developed by the of WHO.

This pathway can be used where diagnostics, medicines, vaccines and vector control products. .

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

The CSA takes place based on a request from a product developer submitted to WHO. It follows an open submission process with a clearly defined single entry point that is the Science Division/Research For Health (SCI/RFH) department. WHO’s advice to the product developer will be coordinated between the relevant technical department(s) and the Prequalification Team through a formal and harmonized process. It is expected that the product proposed by the developer are aligned with existing WHO Target Product Profiles (TPP) or Preferred Product Characteristics (PPC) that provide guidance on unmet public health needs. In the case where no such TPP/PPCs are available, the technical departments will indicate whether the submitted product aligns with a recognized unmet public heath need. The CSA procedure applies to new products, or new/additional data on existing products with the view to assess their potential significant public health value. Together, WHO experts from relevant Technical Department(s) and the Prequalification Team, with assistance from the Research for Health Department, will provide guidance to applicants on the suitability of the development plan and study designs for the generation of relevant data to ensure that the resulting evidence meets WHO’s standards for determining public health value. The CSA procedure takes place in 4 successive steps: Step 1: Determination of Eligibility, where a request from the product developer is evaluated for eligibility, i.e. determines whether the suggested product meets pre-set eligibility criteria. Step 2: Formal application, where the developer submits the full Submission Package to WHO for in-depth review by the technical department(s) and the Prequalification Team. Step 3: Face-to-face/virtual meeting, during which the product developer gets an opportunity to meet the relevant WHO focal points and clarify any outstanding questions and address any issues related to the submission. Step 4: Written report based on the review, outcomes and discussions held during the face meeting will be made available to the product developer. The timeline for the CSA procedure may vary depending on the submission received from the product developer, the nature of the product, its stage of development and the expected advice from WHO. However, the process is expected to take approximately ten weeks from the moment a request is received.