Determination of Pathway
Dependent upon disease specific policy recommendationsThe first required step for WHO evaluation of every new vector control product (VCP) is a determination of pathway. Based on information provided about the type of product, the active ingredient (if applicable), the proposed uses, and the target vectors/diseases to be impacted, the determination of pathway process enables WHO to provide manufacturers with the most applicable guidance regarding the data requirements and procedures to obtain prequalification of the product.
Requesting a determination of pathway
Manufacturers who are interested in participating in WHO evaluation of VCPs must submit a request for determination of pathway (RDP) which includes:
- a cover letter;
- a completed Request for Determination of Pathway Form (PQ100);
- a draft product label (if available); and
- any supplemental information describing the design and intended use of the product which may be helpful in the review of the submission.
Separate RDPs must be submitted for each proposed product. The RDP should be submitted to firstname.lastname@example.org
Determination of pathway process
RDPs are reviewed by the Pre-submission Coordination Committee (PCC) to determine if the proposed product is eligible for prequalification, and accordingly, which pathway is appropriate for the product. For a single RDP submission, there may be multiple outcomes for the determinations of pathway. Each determination is made based on a use/disease combination.
An RDP submission for a proposed product which has uses for IRS and larvicide, and is intended to impact vectors of Malaria and Dengue would result in four determinations of pathway.
If the PCC cannot make a determination based on the information provided, additional information will be requested.
The diagram to the right, “New intervention and prequalification pathways,” illustrates the subsequent processes following from the determination of pathway.
1) Prequalification pathway
The prequalification pathway applies to products that are part of a class for which there is an existing WHO policy recommendation, and is the pathway that all prequalified VCPs complete, so manufactures should be familiar with this pathway even if their product must begin in the new intervention pathway.
When the PCC determines the proposed product can enter the Prequalification Pathway, PQT/VCP is the WHO team responsible for assessing the safety, quality, and efficacy of the product.
- The PQT/VCP Case manager is the point of contact for questions and submission of the required information.
- The PQT/VCP is available for pre-submission meetings to discuss any questions applicants may have and provide additional guidance.
Applicants should carefully review the linked resources below to ensure they understand the procedures for prequalification of VCPs, and the dossier requirements.
- 2018 Joint UNICEF-UNFPA-WHO meeting with manufacturers and suppliers – Workshop on PQT/VCP
- 2019 Joint UNICEF-UNFPA-WHO meeting with manufacturers and suppliers – Making the process clearer
- 2020 Joint UNICEF-UNFPA-WHO meeting with manufacturers and suppliers
- Dossier preparation
2) New intervention pathway plus the prequalification pathway
The New Intervention Pathway applies only to products which are not covered under existing WHO policy recommendations. If the PCC determines the proposed product must enter the New Intervention Pathway, then the product will only become eligible for a prequalification decision once the relevant WHO disease department has established an applicable policy recommendation.
Therefore, the new intervention pathway is two pronged, with a determination of public health value in addition to the standard prequalification pathway.
Determination of public health value
For those proposed products (or new use for an existing product) which are not already classified under an existing policy recommendation, applicants will need to provide additional supporting information that demonstrates the public health value of the product or new use.
Public health value requires proof of efficacy to reduce or prevent infection and/or disease in humans.
The Vector Control Advisory Group (VCAG), provides guidance to product developers, innovators and researchers, through WHO, on the generation of epidemiological data and study designs to enable assessment of the public health value of new vector control interventions. Please contact the VCAG project manager at email@example.com for further information on the requirements and process for the assessment of public health value.
Joint pre-submission meetings including PQT/VCP and the WHO VCAG Secretariat are recommended to provide guidance on the overall process and support the development a project plan to identify the major milestones applicable to the particular case.
Disputing a determination of pathway outcome
Applicants may submit a rationale disputing the determination made by the PCC to PQT/VCP. This must be submitted within 30 calendar days of the determination being communicated.
Once the relevant pathway has been determined, applicants may develop and submit a product dossier which includes data and information to support the safety, efficacy, and quality requirements appropriate to the product type and generated according to good laboratory practices and appropriate quality management system.
Upon submission, the application will be screened for completeness, only complete applications will be accepted for assessment.