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New EUL product listed for IVD

IVD
Announcement
18 September, 2025 - 09:30 (CEST)

On 17 September 2025, the Monkeypox Virus Lyo-PCR Kit, manufactured by Shanghai ZJ Bio-Tech Co., Ltd, was listed as an additional in vitro diagnostic under the Emergency Use Listi

AMA training

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Announcement
17 - 19 September, 2025 - 13:00 - 18:00 (CEST)

On 17, 18 and 19 September 2025, the WHO Prequalification Unit, Medicines Assessment Team is organizing a Training for African Assessors and EMP-TC Members under AMRH and the future African Medicin

New EUL listing

IVD
Announcement
17 September, 2025 - 09:52 (CEST)

An additional in vitro diagnostic has been listed under the Emergency Use Listing procedure.

Lupin’s pretomanid tabl prequalified

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9 September, 2025 - 00:12 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

  • TB403 Pretomanid 200mg tablets - Lupin Limited - INDIA

WHO prequalifies the first triple diagnostic test

IVD
Announcement
11 July, 2025 - 15:05 (CEST)

WHO has granted the first prequalification listing of a bundle of three diagnostics tests to be used for pregnant women for the qualitative detection of HIV, Hepatitis B Surface Antigen, and Trepon

Active Pharmaceutical Ingredient (API) Prequalified

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Announcement
8 July, 2025 - 12:12 (CEST)

Rifampicin form I (WHOAPI-521) manufactured by Hebei Xingang Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.

Q2 2025 Newsletter

IVD
Announcement
4 July, 2025 - 16:13 (CEST)
The In Vitro Diagnostics Assessment Team has published the Q2 2025 Newsletter summarizing the main news. 
You can access the New

Active Pharmaceutical Ingredient (API) Prequalified

M
Announcement
9 June, 2025 - 00:12 (CEST)

Rifampicin (WHOAPI-520) manufactured by Hebei Xingang Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.