Frequently asked questions on the WHO Coordinated Scientific Advice Procedure
Why should product developers apply for CSA?
The CSA procedure has been developed to assist health product developers in obtaining joint advice from the WHO technical departments in charge of policy development for implementation of health interventions and from the WHO Prequalification Team in charge of the assessment of specific health products for priority diseases and conditions, in line with WHO recommendations. The overall aim of the WHO CSA is to accelerate timelines to implementation and access to innovative health products that meet a global health need by ensuring requirements for policy development and prequalification are considered from the product design stage and incorporated in trials designs and validation studies.
What is the scope of the CSA?
The CSA procedure is intended to support product developers of diagnostics, medicines, vaccines and vector control products. The current pilot is accepting requests for diagnostics, medicines and vaccines. It is envisaged that vector control products will be part of the final procedure. For more information, contact ScientificAdvice@who.int.
How long does the CSA procedure take?
In the pilot phase the CSA procedure is expected to be completed within 10 weeks, starting from the receipt of a complete request for CSA from the product developer. Timelines will ultimately depend on the complexity of the product submitted, the questions submitted by the product developer, and the quality of the submission.
Who should request CSA?
WHO recommends that the request for CSA is initiated and managed by the party that will be responsible for submitting an application for WHO Prequalification in order to ensure the subsequent implementation of the advice provided. In general, CSA requests are expected to be submitted by manufacturers. The product developer applying for a CSA may choose to involve any partner organization that is supporting the development of the product at any point in the CSA process.
The designated contact provided in the request form will be the primary contact point for any communication between WHO and the product developer applying for CSA. The product developer will communicate to WHO any additional contacts that need to be included in the list of participants for the CSA meeting.
What is the cost of a CSA procedure?
The CSA procedure is a free service provided by WHO.
What are the eligibility criteria?
Requests will be considered for innovative products (or combinations of products) under development, not yet commercially available as well as commercially available products under development for additional indications/uses. In either of these cases, the product has to be associated with potential significant public health value.
Requests will be considered for products under development that fall within the scope of PQ. Under certain circumstances and in agreement with relevant technical departments at WHO and the Prequalification Team, a request for a product that is not currently within the scope of PQ may be considered.
Who prioritizes product health needs?
The WHO CSA is aimed at products that 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 exist, the WHO technical department(s) will indicate whether the submitted product aligns with a recognized unmet public heath need.
When should product developers initiate a CSA request?
The optimal time for initiating a CSA request will vary depending on the type of product. In general, it will be before the pivotal trial(s) design is/are finalized in the case of therapeutics and vaccines, or before the start of clinical validation studies for IVDs. Under certain circumstances WHO may consider a CSA request at an earlier stage of development. Ultimately, the timing for CSA requests will be determined by the product developers’ needs based on the products under development. WHO may be contacted at any stage to discuss ahead of a formal request. For more information contact: ScientificAdvice@who.int
What kind of information is included in a CSA request?
- Eligibility determination: The applicant is requested to submit general information about the product and the specific questions for which they require scientific advice. Detailed positions of the product developer on these questions along with any supporting data are not required at this stage of the process.
- Submission package: Adequate preparation is important. Product developers should submit accurate and complete information in a concise manner. WHO responses and comments will be primarily based on the specific questions and the submitted product developer positions.
Product developers should limit their submission to information, data and evidence allowing WHO to directly answer the specific questions for which the product developer is seeking advice. Including excessive, unnecessary documentation is counterproductive and will be returned to the applicant without review.
It is important to note that the CSA procedure is not a pre-evaluation ahead of a potential WHO Prequalification submission. WHO responses in a CSA do not pre-empt outcomes of any future WHO Prequalification application.