El 12 de mayo de 2017 celebramos en la Fundación Ramó Areces una jornada con IS Global y Unitaid sobre enfermedades transmitidas por vectores, como la malaria, entre otras.

1. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Global Malaria Programme
Prequalification Team
Department of Control of Neglected Tropical Diseases
Overview of revised WHO evaluation
process to support introduction of
new vector control products
Bringing innovation to the front-line:
New tools to advance the global response to vector-borne diseases
11-12 May 2017, Fundación Ramón Areces, Madrid, Spain

2. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Background
• WHO process for evaluation of vector control
products has been revised: WHO Pesticide Evaluation
Scheme (WHOPES) → Prequalifications Team (PQT)
• Revised process came into effect on 1 January 2017
• Objectives are to:
1. Enable access to safe, effective and high-quality vector
control products;
2. Enhance evidence-based guidance to promote best
use and management of vector control tools,
technologies and approaches;
3. Promote product quality throughout the product’s life
cycle.

3. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Key Features
• The revised process consists of two pathways:
• Prequalification Pathway
• New Interventions Verification Pathway
• Evaluation pathway is determined by whether or not a
product is part of a product class with an existing
WHO policy recommendation
• Requirement for policy recommendation prior to
prequalification aligns process for vector control
products with that for medicines, vaccines,
diagnostics, and other medical equipment and devices

4. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Revised Evaluation Process – Pathway Determination
• Process starts when a product developer/manufacturer submits a pre-
submission package for a vector control product via single entry portal managed
by PQT
• Pre-submission Coordination Committee [PQT, GMP and NTD] reviews
application and determines pathway
• PCC provides feedback to the product developer/manufacturer on process and
requirements for WHO evaluation
• Applicant should then submit a full application as directed

5. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Revised Evaluation Process – PQT Pathway
• Applicant needs to develop full product dossier
based on the safety, efficacy, and quality
requirements as outlined in PQT-VC procedure
• Application will be screened for completeness
• Once application is complete, two parallel
activities commence:
1. Assessment of the application by experts at
the Assessment Session for Vector Control
Products (ASVCP);
2. Inspection of the manufacturing facilities to
ensure compliance with WHO-
recommended quality standards
• Decision on prequalification will be made based
on review of the submitted application and the
outcome of inspections
• Post-prequalification activities: product change
management (formulation and labelling), post
marketing surveillance, product testing, and
periodic monitoring of manufacturing sites

6. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
• Draws on Vector Control Advisory Group (VCAG)
• Product concept reviewed to determine data
required to:
a) assess new product class or claim
b) assess public health value
Public health value = proven protective efficacy to
reduce or prevent infection and/or disease in humans
• Applicant advised on data required and appropriate
trial designs
• VCAG supports development of risk assessment
framework & product specifications
• Applicant then needs to develop study protocol,
identify testing sites and generate data
• Data will be assess by VCAG & recommendation on
public health value made to WHO
• Policy recommendation & operational guidance
• PQT inspection process conducted in parallel with
data assessment, to ensure completion coincides
with publication of policy recommendation
• Product becomes eligible for prequalification
Public health value = proven protective efficacy to
reduce or prevent infection and/or disease in humans
Revised Evaluation Process – New Interventions

7. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Revised Evaluation Process

8. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Transition from WHOPES to PQT
• During transition all products with a WHOPES recommendation
(interim or full) will be given time-limited WHO prequalification
and be listed accordingly
• To ensure clarity the time-limited listing will:
 specify the product’s suitability with respect to the eligibility
criteria
 the claims for which it has been assessed
 whether additional data are required for further product
evaluation
 timeframe for the product developer to provide these data
• If data requirements are not met within the specified
timeframe, the product will be delisted.

9. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
WHO Policy Recommendation

10. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
http://www.who.int/malaria/publications/atoz/vector-control-recommendations/en/

11. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Global Malaria Programme
Prequalification Team
Department of Control of Neglected Tropical Diseases
Thank you