Prequalification Procedures and Fees

Fees for prequalification

Currently, there are NO FEES associated with the prequalification of vector control products (VCPs) nor the assessment for the development of specifications.

Fee for service models are under consideration, but no determination has been made at this time. Any decisions about implementing a fee based model will be made with stakeholder consultation.

Background

The key objectives of VCP prequalification are to:

  1. increase access to safe, effective and high-quality VCPs;
  2. enhance evidence-based guidance to promote best use and management of vector control tools, technologies and approaches; and
  3. promote product quality throughout the product’s life cycle.

Beginning 1 January 2017, the WHO process for the evaluation of VCPs was revised to better meet the needs of countries endemic for, or at risk of, vector-borne diseases.

The revised process accelerates product evaluation, expands the vector control toolbox for malaria and neglected tropical diseases, and addresses key challenges such as emerging vector resistance to insecticides.

The document Draft Overview of the WHO Prequalification Assessment of Vector Control Products was developed to provide manufacturers and other stakeholders with an overview of the WHO prequalification assessment process for VCPs. Manufacturers wishing to apply for WHO prequalification of their product(s) should read this document before applying, so that they can be aware of, and prepared for, all aspects of the prequalification assessment process.

Prequalification service codes and target review times

The VCP Prequalification process relies on a service based approach, in which applications are considered requests for specific services throughout the prequalification process.

The process and timeline for prequalification depends upon the service(s) requested and the data and documentation submitted, as well as other factors; there is, therefore, some variation in the length of prequalification and post-prequalification activities.

The table below provides a summary of target review times for new VCP evaluation and prequalification as well as the Service Codes for each service.

Detailed information is available here.

Service code

Name

Target review time

PQ100

Request for determination of pathway

2 months

PQ200

Protocol review

3 months

PQ300

New product

12 months

PQ301

New equivalent product

12 months

PQ400

New specification for source material (TC/TK or other)

12 months*

PQ401

Extension of existing specification for source material (TC/TK or other)

12 months*

 

PQ500

PPQC: major

7 months*

PQ501

PPQC: minor

3 months

PQ510

Change to specification/production of source material (TC/TK or other) 

12 months*

* For those actions which include JMPS review, the target review time may vary.

The pages below provide detailed information on the prequalification process.