Technical Advisory Group Vector Control Products Regulation (TAG-VCPR)

The mandate of the Vector Control Products Assessment Team of the World Health Organization Prequalification Unit (WHO PQT-VCP) is to increase access to safe, high-quality and effective Vector Control Products (VCPs). Product dossiers, submitted by manufacturers, are assessed individually to determine if each product meets the established WHO standards for prequalification. The work of WHO PQT-VCP is furthered through cooperation with national regulatory agencies (NRA) and partner organizations to ensure that quality VCPs are available to those who need them.

Through evaluation, inspection and guidance activities, WHO PQT-VCP:

• Prequalifies VCPs that are safe, effective and manufactured to a high quality, and publishes a list of these prequalified products;
• Ensures the continued validity of the prequalification decision for products throughout their regulatory life cycle; and
• Contributes to building the assessment capacity of Member State National Regulatory Authorities (NRAs); by
  • training assessors from Member States through WHO assessment sessions;
  • harmonizing quality and regulatory systems;
  • supporting collaborative registrations of prequalified VCPs.

In the absence of legislation, the framework for the prequalification assessment for VCPs is based on science and policy.  Implementation of the established programme requires that existing scientific guidance, data requirements and operational policies are periodically reviewed, updated and expanded to encompass innovative tools and technologies that new aspects are developed.  The landscape for vector control (VC) is rapidly evolving, leading to novel products/delivery mechanisms across the categories of conventional public health pesticides, microbial organisms/agents, and modified organisms including gene-drive based technologies.   

Considering these factors, the establishment of a technical advisory group is necessary to ensure impartiality and transparency of prequalification processes for development of guidance and policies related to the prequalification of VCPs. WHO will call upon the Technical Advisory Group on WHO Vector Control Products Regulation (TAG-VCPR) to provide advice to WHO on these activities, thereby providing an additional level of assurance that due process was followed and that WHO guidance and policies are supported by evidence-based procedures and reflect good regulatory practices.

The Technical Advisory Group on WHO Vector Control Products Regulation (TAG-VCPR) acts as an advisory body to WHO in this field.

TAG-VCPR is managed by the Vector Control Products assessment team at the World Health Organization Prequalification unit (WHO PQT-VCP) at the Regulation and Prequalification Department.

TAG-VCPR functions

In its capacity as an advisory body to WHO, the TAG-VCPR shall have the following functions:

• To provide regulatory advice on the procedures related to the assessment of VCPs and vector control active ingredient (VCAIs) used in the formulation of end use VCPs;
• To provide advice on the development, revision and adoption of policies, guidelines and guidance in response to advancements of technologies in VC and the progression of the PQT-VCP activities, e.g.
  • Regulatory frameworks for existing and novel products
  • Guidelines and guidance, including data requirements, for pre-market assessment
  • Guidelines and guidance for post-market monitoring and surveillance;
• To provide advice on the workplan and prioritization of activities/initiatives within the scope of prequalification of VCPs, and other related activities.       

Meeting and operational procedures

In the exercise of their advisory function, members of TAG-VCPR shall serve in their personal capacity, as international experts advising WHO exclusively; and in that capacity they respect the impartiality and independence required, are free of any real, potential or apparent conflicts of interest and provide WHO with the best possible advice. TAG members will not be remunerated for their participation in TAG-VCPR; they are appointed to serve for a period of 3 years and are eligible for reappointment.

The TAG-VCPR shall normally meet at the request of WHO to provide regulatory advice on the PQT-VCP procedures, advise WHO PQT-VCP on the adoption of policies, and advise on the prioritization and inclusion of activities/initiatives on the WHO PQT-VCP programme of work. TAG-VCPR meetings will be convened by WHO and will be held virtually, via video or teleconference, or in-person (at WHO headquarters in Geneva or another location, as determined by WHO). Frequency may be adjusted by WHO as necessary. For more information please see the Terms of Reference of the TAG-VCPR.

Secretariat

WHO shall provide the secretariat for the TAG-VCPR, including necessary scientific, technical, administrative and other support. The Prequalification Unit – Vector Control Products Assessment Team (PQT/VCP) under the Regulation and Prequalification (RPQ) Department, Access to Medicines and Health Products (MHP) Division of WHO serves as the secretariat of TAG-VCPR.