WHO – Procedure for Prequalification of Vector Control products
Manufacturers wishing to apply for WHO prequalification of their product(s) are invited to read more about the prequalification assessment process.
WHO - PQT VCPAG Workshop on Dossier Requirements and Proposed Inspection Protocol 26-28 October 2016
On 26-28 October 2016, WHO hosted a workshop entitled “WHO PQT VCPAG Workshop on Dossier Requirements and Proposed Inspection Protocol.” The workshop covered three topics:
- Day 1 – Dossier Requirements for New Active Ingredients Developed Initially for Vector Control
- Day 2 – Dossier Requirements for New Vector Control Products
- Day 3 – Draft Prequalification Quality Assurance Process for Vector Control Products
Information regarding the workshop can be found here.
We would like to thank everyone for the feedback and comments provided in response to the workshop. PQT-VC is working to address these comments through the development of guidance materials.
All feedback received in response to the workshop has been considered by WHO as it has been developing its procedures, and is reflected in the many documents now posted on the websites of the NTD, GMP and PQT-VC. Stakeholders are encouraged to read through these documents as many of the comments and questions received following the workshop are addressed.
The comments received were grouped into categories and themes. The responses pertaining to process and policy, inspection and data requirements are collated in the document below.
WHO - IVCC Stakeholder Presentation 06 June 2016
On 06 June 2016 at the Innovative Vector Control Consortium (IVCC) Stakeholder meeting in Manchester, UK, WHO delivered a presentation on the transition of vector control product assessment from the WHO Pesticide Evaluation Scheme to the WHO Prequalification Team (PQT). The presentation elucidates key activities, roles of WHO units within the transition, and staffing of the new PQ Vector Control Group.
Revised diagrams were presented illustrating proposed regulatory pathways for vector control products. These diagrams reflect feedback from stakeholders, however elements within the charts are yet to be finalized.
Building regulatory pathways for vector control products
WHO hosted an informal meeting with vector control industry stakeholders on 17 May 2016. The purpose of the meeting was to share new regulatory pathways proposed by the WHO Prequalification Team, in order to seek feedback on the approach and proposed timelines. The presentation delivered at the meeting outlines the core approaches toward building regulatory pathways, including the identification of responsible stakeholders and key steps.
Example pathways, shown on slide 12 and expanded upon in slides 13 to 18, were developed for (a) new products, (b) generic products, and (c) variations of previously assessed products that can be evaluated as existing vector control paradigms, such as long-lasting insecticide treated bed nets (LLIN), indoor residual sprays (IRS), space sprays or larvicides. The assessment of a new paradigm (an intervention concept where public health efficacy is not yet established) requires a review by the Vector Control Advisory Group (VCAG) under the Control of Neglected Tropical Diseases department/Global Malaria Programme, in order to identify dossier submission requirements to support the proposed product. A new paradigm, once reviewed, may become an existing paradigm for which a new regulatory pathway will be defined under PQT.
Based on feedback from meeting participants, the proposed pathways are now in the process of being updated. Proposed pathways and final pathways, as well as guidance documents, will be posted on the PQT-vector control website as these become available.
- Key performance indicators for WHO prequalification
- Global public consultation on WHO prequalification of similar biotherapeutic products
For general enquiries:
WHO Prequalification Team
Vector control products
World Health Organization
20, Avenue Appia
1211 Geneva 27