What We Do
We prequalify in vitro diagnostics
The aim of WHO prequalification of in vitro diagnostics (IVDs) is to promote and facilitate access to safe, appropriate and affordable in vitro diagnostics of good quality in an equitable manner. The focus is on IVDs for priority diseases that are appropriate for use in resource-limited settings.
WHO IVD prequalification incorporates comprehensive assessment of individual IVDs through a standardized procedure, to determine whether the product meets WHO prequalification requirements. Assessment has three components:
- review of a product dossier
- laboratory evaluation of performance and operational characteristics
- manufacturing site(s) inspection
Following prequalification post-market surveillance is undertaken. It includes reactive and proactive measures, through complaint reporting and post-shipment/pre-distribution lot testing. Post-qualification also includes mandatory manufacturer notification of changes to the product or the quality management system.
The WHO Prequalification Unit performs assessments of in vitro diagnostics (IVDs) to verify compliance with quality, safety and performance requirements. Three distinct assessments can be undertaken, depending on a number of aspects outlined below.
Table 1 summarizes the main differences among the three assessment mechanisms: (1) Prequalification – PQ, (2) Expert review panel – ERPD and (3) the Emergency Use Listing procedure – EUL.
Table 1: Comparative assessments table
| PQ | ERPD | EUL | |
|---|---|---|---|
| Scope/eligibility | Defined PQ eligibility criteria |
|
Defined in the EUL EOI (PHEIC-driven) |
| Responsible for EOI/eligibility | WHO Prequalification Unit based on an agreement with the respective WHO technical programme |
|
WHO Prequalification Unit in agreement with WHO/WHE |
| Timing | Open call for applications within eligibility criteria | Defined in each ERPD EOI | Defined in the EUL EOI (PHEIC-driven) |
| Responsibility for receiving applications | WHO Prequalification Unit |
|
WHO Prequalification Unit |
| Assessment fees | PQ fees payable | No fees payable | No fees payable |
| Responsible for the technical review | WHO Prequalification Unit | WHO Prequalification Unit | WHO Prequalification Unit |
| Assessment components |
|
|
|
| Requirements | Defined in PQ documents, including PQ Technical Specifications (TSS) | Risk-based approach | Essential data requirements outlined in the EUL instruction document |
| Outcome | Products that meet requirements added to WHO Prequalification List | A Risk Category for procurement will be assigned | Products that meet requirements added to WHO Emergency Use List |
| Publication of assessment outcomes | For PQ-listed products only
|
Managed by the agency/programme responsible for EOI/eligibility | For listed products and products which failed EUL listing
|
Dossier review
Transition to the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format for product dossier submissions
Manufacturers should compile and submit the product dossier as prescribed in PQDx_018 - Instructions for Compilation of a Product Dossier – IMDRF ToC and Table of Contents (TOC) Product Dossier Checklist. Please direct any enquiries to diagnostics@who.int.
WHO reviews the product dossier to:
- assessing evidence in support of safety and performance of the product
- determining whether the manufacturer's quality management system is of an adequate standard to warrant an inspection of the manufacturing site
- assessing product design and manufacture.
If the dossier is incomplete, the manufacturer will be requested to submit additional information within a specified time period. Once a dossier has been accepted, assessment can proceed to the laboratory evaluation and manufacturing site inspection.
We prequalify male circumcision devices
WHO staff responsible for prequalification of IVDs also undertake prequalification of male circumcision devices.
The approach and standards applied to prequalification of MCDs are very similar to those applied for IVD prequalification.
Our key outputs
The key outputs for WHO immunization devices prequalification are: