The World Health Organization (WHO), through its Prequalification Unit and Global Tuberculosis Programme, would like to announce that the transition period for WHO procurement eligibility of TB NAT assays based on the WHO endorsement mechanism has been extended from the previously communicated date (31 December 2024) until 31 December 2025. Several prequalification applications are undergoing assessment, this additional time will allow to complete the ongoing assessments. This measure only applies to products submitted and accepted for WHO prequalification assessment. After 31 December 2025 all products will have to be covered by a WHO recommendation and Prequalified to be eligible for procurement by WHO and other UN/International Procurement Agencies.
Please find below a summary of key dates:
Q3 2022 | Q1 2023 | Q4 2025 |
PQ TSS-17 published, and applications invited Workshop held for manufacturers | Deadline for currently endorsed TB NAT assays submissions for PQ assessment | Deadline for PQ listing of currently endorsed TB NAT assays |
Information on the prequalification applications status and the list of prequalified IVDs can be accessed on the WHO website.