WHO PREQUALIFICATION
OF IN VITRO DIAGNOSTICS UPDATE

PREQUALIFIED IVDs

Despite the substantial workload and prioritization of EUL assessments the Prequalification Team continues to work hard on prequalification assessments.

No product was prequalified for this edition of the newsletter.

COVID-19 PANDEMIC AND EMERGENCY USE LISTING

Emergency Use Listing (EUL) for candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 remains ongoing.

Thus far we have received over 167 expressions of interest and 29 products have been listed as eligible for WHO procurement based on their compliance with WHO EUL requirements:  24 NAT assays, 4 antigen detection RDTs and 1 antibody detection assay.  There are currently 89 active applications in the assessment pipeline and 50 products were not accepted for WHO EUL listing. The status of each application is updated weekly on our webpage and in the link below.

Please note that our Team is receiving a very high volume of requests for Emergency Use Listing of in vitro diagnostics. We therefore are unable to respond to applicants' requests for status updates.

ENHANCING THE EMERGENCY ASSESSMENT - ASSESSORS TRAINING

9TH ANNUAL COLLABORATIVE  REGISTRATION PROCEDURE

The 9TH annual collaborative registration procedure (CRP) meeting for National Regulatory Authorities (NRAs) was held 13 - 17 December. Participant were introduced to the significant added value of the WHO-PQ process in enabling, promoting and facilitating access to safe, appropriate and affordable In-vitro diagnostics of good quality in an equitable manner. The CRP was presented as a pathway for the WHO PQ outcomes to be leveraged by NRAs to considerably accelerate In-country approvals of prequalified IVDs.

IVD's DETECTING M.TUBERCULOSIS -
COMING SOON TO PQ

A Technical Consultation on WHO Prequalification Requirements for Mycobacterium tuberculosis complex (MTBC) NAT assays was held 22-24 November. The purpose of the consultation was to review the draft technical specifications series (TSS) document, which outlines the analytical and clinical performance studies that manufacturers will be required to perform and submit in their product dossier for prequalification assessment.

GLUCOSE MONITORING DEVICES -
COMING SOON TO PQ

An online information session about the Prequalification of glucose monitoring devices was held for manufacturers on Friday 5 November. The PQ Team provided an overview of the assessment process, a project timeline for the prequalification of glucose monitoring devices and details of the guidance available for manufacturers.