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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

M
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.

Expanded reliance mechanisms

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Announcement
1 June, 2025 - 12:12 (CEST)

PQT/MED currently has two major prequalification pathways – the full assessment pathway for generics not approved by a Stringent Regulatory A

Active Pharmaceutical Ingredient (API) Prequalified

M
Announcement
22 April, 2025 - 12:12 (CEST)

Dolutegravir (sodium) manufactured by Styrax Pharma Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.

Active Pharmaceutical Ingredient (API) Prequalified

M
Announcement
29 January, 2025 - 00:12 (CET)

Albendazole (WHOAPI-427) manufactured by Sequent Scientific Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.