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WHO PREQUALIFICATION
OF IN VITRO DIAGNOSTICS UPDATE
Issue 41 - Q1 2023
PREQUALIFIED IVDs
Despite the substantial workload and prioritization of EUL assessments, the Prequalification Team continues to work hard on prequalification assessments.
There were no IVDs that were prequalified in the last quarter.
COVID-19 PANDEMIC AND EMERGENCY USE LISTING
WHO continues to assess SARS-CoV-2 IVDs under the Emergency Use Listing (EUL) procedure. Antigen detection RDTs intended for professional use and self-testing, as well as point of care NAT assays are prioritised for assessment. Currently 3 antigen detection RDTs for self testing, 12 antigen detection RDTs for professional use, and 21 NAT assays are listed.
For more information on EUL-listed products, please refer to our website.
The WHO International Standard for Antigen RDTs is now available for purchase from NIBSC.
UPDATED ELIGIBILITY CRITERIA FOR PREQUALIFICATION ASSESSMENT
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Finalized technical specifications documents for hepatitis B IVDsThe finalized technical specifications documents which outline the analytical and clinical performance study requirements for hepatitis B IVDs (RDTs, EIAs and NAT assays) are available below. Interested manufacturers are invited to contact the PQ Team to discuss their IVD. |
Public consultation for TSS-18
The public consultation on technical specifications for haemoglobin A1c point of care analysers (TSS-18) has been closed. The PQ IVDs team thanks all contributors for their valuable comments. The final version is expected to be published in Q2.
IMDRF - ToC FORMAT
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WHO PQ has implemented the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format for product dossier submissions. This replaces the Global Harmonization Taskforce (GHTF) Summary Technical Documentation (STed) format for product dossiers. As of 2023, manufacturers wishing to apply for WHO prequalification of IVDs should compile and submit when requested their product dossier as prescribed in PQDx_018 v5 - Instructions for Compilation of a Product Dossier – IMDRF ToC and Table of Contents (TOC) Product Dossier Checklist. Dossiers in STeD format will no longer be accepted. |
WHO IVD PQ AND EUL UKRAINE WORKSHOP
In partnership with the European Regional Office and WHO Country Office in Ukraine the PQ IVD Assessment Team held a virtual Workshop on the 10th of February with regulators from the National Regulatory Authority and IVD manufacturers based in Ukraine. Details about the Workshop are available in the link below.
WHO COLLABORATIVE REGISTRATION PROCEDURE - UPDATE FOR IVD MANUFACTURERS
The PQ IVD Assessment Team held a virtual Workshop on the 15th of March with manufacturers to provide an update on implementation of the Collaborative Registration Procedure (CRP). The objectives of this workshop were to highlight the CRP principles and objectives, the process for participation, the National Regulatory Authorities currently engaged and upcoming plans for expanding support of the collaborative process. The workshop recording is available below.
ROSTER OF CONSULTANTS
The In Vitro Diagnostics Assessment Team is looking for additional consultants who can support the team’s work across prequalification, Emergency Use Listing and Expert Review Panel assessments. Subject matter experts interested in becoming a consultant to WHO can submit their application through the WHO Stellis portal.
In Vitro Diagnostics Assessment Team
Prequalification Unit
Regulation and Prequalification Department
Access to Medicines and Health Products Division
World Health Organization
