WHO list of prequalified in vitro diagnostic products updated
IVD
News
Registration is open for Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers
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10th Invitation to manufacturers of reproductive health products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines
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Addition:
Under section: 9. Antifibrinolytics
22nd Invitation for Expression of Interest (EOI) to manufacturers of antimalarial medicines published
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New Invitation for Expression of Interest (EOI) to manufacturers of antimalarial medicines published
Addition:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Molnupiravir (WHOAPI-449) manufactured by Shanghai Desano Chemical Pharmac
Newly prequalified Active Pharmaceutical Ingredient (API)
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Molnupiravir (WHOAPI-438) manufactured by Optimus Drugs Pvt Ltd, has been
Huayi’s sulfamethoxazole/trimethoprim tablets prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequa
WHO Prequalification Team - Medicines (PQT/MED) has issued new guidance on the recommended style to be used for visual description of oral dosage forms in WHO Public Assessment Reports (WHOPARs)
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WHO Prequalification Team - Medicines (PQT/MED) has issued a new guidance on the recommended style to be used for visual description of oral dosage forms in WHO Public Assessment Reports
Beijing Holley-Cotec’s DHA/piperaquine tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Celltrion’s nirmatrelvir + ritonavir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Update on N-nitrosamine impurities
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Applicants are reminded of the latest N-nitrosamines assessment policies for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs):
Newly prequalified Active Pharmaceutical Ingredient (API)
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Nirmatrelvir (WHOAPI-469) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd, has been prequalified by the WHO Prequalification Team: Medicines under its API prequalification procedure.
Ipca’s higher strength artesunate injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First rifapentine generic prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ paediatric linezolid tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Laurus’ atazanavir/ritonavir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ lopinavir/ritonavir, including paediatric tablet, prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Human Insulin Master File (h-IMF)
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Diabetes mellitus is a public health challenge due to its high and increasing prevalence and associated morbidity and mortality that have health and economic impact on indi
Resolution of Notice of Concern (NOC)
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A-31 Clinical Unit I at Accutest Research Laboratories (I) Pvt. Ltd has addressed the concerns highlighted in the Notice of Concern (NOC) by the WHO.
Guilin’s pyrimethamine/sulfadoxine dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Universal’s pyrimethamine/sulfadoxine + amodiaquine dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
PQT/MED publishes first invitation to manufacturers of medicinal products for treatment of disorders caused by use of tobacco, to submit an Expression of Interest (EOI)
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A first invitation to manufacturers of medicinal products for treatment of disorders caused by use of tobacco, to submit an Expression of Interest (EOI) for product evaluation
Malaria Rapid Diagnostic Tests: Intended Use Statement
IVD
The In Vitro Diagnostics Assessment Team acknowledges that there have been inconsistencies in the intended use statements presented in various Instructions for Use (IFUs) of prequalified malaria Ra
First oral zinc solution prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PharmEvo’s dispersible zinc tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Molnupiravir (WHOAPI-
Strengthening the Quality Management System for Manufacturers of Local Medical Device through WHO Prequalification (WHO-PQ)
IVD
In collaboration with the WHO Indonesia Country Office the PQT-IVD Team contributed to a workshop hosted by the Directorate of Pharmaceutical and Medical Devices Resilience, Ministry of Health, Ind