WHO Public Assessment Reports (WHOPARs) published
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News
WHO grants approval for use of Bavarian Nordic’s mpox vaccine in adolescents
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On 8 October 2024, WHO granted prequalification for the age-extension of the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine for use in adolescents aged 12 to 17 years, expanding its indi
Lupin’s isoniazid/rifapentine tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Recent Highlights
IVD
On 14 October 2024 WHO listed the second mpox IVD under the WHO Emergency Use Listing (EUL) procedure.
Public consultation on proposed revisions to the WHO Prequalification of in vitro diagnostics assessment process
IVD
WHO has identified the need to revise the WHO prequalification processes for IVDs to address the growing need for increased access to quality assured IVDs in low and middle-inco
For Public Consultation: New proposed version of the Guidance on reportable changes to IVDs
IVD
WHO is seeking for public comments on a new proposed version of the Guidance on reportable changes to IVDs (deadline for submission of comments by 15 November 2024).
Active Pharmaceutical Ingredient (API) Prequalified
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Dolutegravir (sodium) manufactured by Aurore Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Shanghai Desano’s nirmatrelvir + ritonavir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Sun Pharmaceutical’s atazanavir/ritonavir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Two PQT Medicines workshops for manufacturers
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The PQT Medicines 7th Annual Medicines Quality Workshop for Manufacturers will take place from 23 to 26 September 2024.
Active Pharmaceutical Ingredient (API) Prequalified
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Molnupiravir manufactured by Aurore Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Active Pharmaceutical Ingredient (API) Prequalified
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Tranexamic acid manufactured by Ami Lifesciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Shanghai Fosun’s nirmatrelvir + ritonavir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Indoco’s chewable albendazole tablets prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shijiazhuang Lonzeal’s tenofovir disoproxil against hepatitis prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Swiss Pharma Nigeria’s sulfadoxine/pyimethamine tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First chewable albendazole prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s rifampicin/isoniazid/pyrazinamide dispersible tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Emcure’s dolutegravir/lamivudine/tenofovir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shanghai Fosun’s molnupiravir capsule prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shanghai Desano’s molnupiravir capsule prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s rifapentine tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO prequalifies the first self-test for hepatitis C virus
IVD
10 July 2024 – The World Health Organization (WHO) has preq
Shanghai Desano's ritonavir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Reyoung Pharmaceutical's sulfamethoxazole/trimethoprim tabl prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO PQT-IVD Webinar – New Applicants to IVD Prequalification
IVD
A webinar for IVD manufacturers was held on 26 June.
REGISTRATION OPEN: 2024 annual joint UNICEF-UNFPA-WHO meeting with manufacturers and suppliers
IVD
Dear Colleagues,
WHO PQT-IVD Webinar – Product Dossier Assessment
IVD
A webinar for IVD manufacturers was held on Wednesday 29 May to share information about prequalificati
Performance evaluations for IVDs for monitoring of blood glucose in capillary blood and HbA1c PoC Assays
IVD
On 12 April 2024 WHO announced the expansion of prequalification of in vitro diagnostics to include diabetes.
Macleods’ artesunate 120 mg for injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Mylan’s molnupiravir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list: