a. Prequalification of products with a WHO policy recommendation

The newly established WHO prequalification programme undertakes the following functions:

• assessing the efficacy, safety, and quality of vector control products based on dossier submitted by manufacturers;
• conducting inspection of the corresponding manufacturing sites;
• building the capacity of national regulatory authorities and quality control laboratories, and
• undertaking post-market surveillance.

When a vector control product has been assessed by WHO and found to be acceptable for its intended use, it is included in the so-called “prequalified list”. This means that the product, in principle, can be procured by UN and other international agencies and national buyers for vector control purposes.

Depending on whether the product is an existing vector control tool, which has a WHO policy recommendation, or it is a new tool, a different evaluation pathway is followed. The graphic below summarizes the WHO evaluation process for vector control products. It also indicates which outcomes of these evaluations can be used by national/regional regulatory authorities when assessing and authorizing vector control pesticides.

Evaluation process for vector control products by WHO,and its outputs that can be used by pesticide registration authorities

Vector control products that already received a WHO Policy Recommendation (i.e. a proven impact on disease) are evaluated through the so-called prequalification pathway. An applicant for prequalification listing submits a product dossier consisting of safety, efficacy and quality data, which is subsequently assessed; manufacturing facilities are also inspected. The FAO/WHO Joint Meeting on Pesticide Specifications (JMPS) is the advisory body that assists in developing product specifications based on the manufacturer data.

If a product is added to the Prequalification List, a WHO Decision Document and a Quality Specification will be published. Products which had received a recommendation for use under the previous system of the WHO Pesticide Evaluation Scheme (WHOPES) until 2016, may now apply for a conversion to the Prequalification Listing. The efficacy and risk assessments for these products are summarized in the WHOPES Working Group Reports. All these documents are available on line from the WHO Prequalification Team and form a good basis for decision making by national/regional registration authorities (Click on the product name to access the report page for that product).

b. Assessment of public health value of new intervention class

A vector control product or tool that does not fall in an established class (i.e. without a WHO policy recommendation) cannot yet be prequalified until a public health value assessment by the WHO Vector Control Advisory Group (VCAG) has been done. On the basis of a positive recommendation, WHO may issue a policy recommendation and operational guidance. It can then enter the prequalification pathway and possibly be listed. Evaluations of new vector control tools are published in the VCAG Session Reports, which again can provide important information for national/regional regulatory authorities. 

A more detailed overview of the evaluation process for vector control products is available from WHO-PQT.