Table of In Vitro Diagnostics Under Assessment for HIV Nucleic Acid Tests updated
IVD
News
Guilin’s artemether/lumefantrine tablets prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
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New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
Addition under section:
IVD's Detecting M. Tuberculosis - Coming Soon to PQT
IVD
A Technical Consultation on WHO Prequalification Requirements for Mycobacterium tuberculosis complex (MTBC) NAT assays was held 22-24 November.
Glucose Monitoring Devices - Coming Soon to PQT
IVD
An online information session about the Prequalification of glucose monitoring devices was held for manufacturers on Friday 5 November.
9th Annual Collaborative Registration Procedure
IVD
The 9th annual collaborative registration procedure (CRP) meeting for National Regulatory Authorities (NRAs) was held 13 - 17 December.
Enhancing the Emergency Assessment - Assessors Training
IVD
The In Vitro Diagnostics Assessment Team continues its focus on assessing IVDs for detection of SARS-CoV-2 under the WHO Emergency Use Listing assessment procedure.
Dexamethasone injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Nirmatrelvir + ritonavir added to COVID-19 Invitation for Expression of Interest (EOI)
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Nirmatrelvir 150mg tablets + ritonavir 100mg tablets invited for COVID-19.
WHO list of prequalified in vitro diagnostic products updated
IVD
The WHO list of prequalified in vitro diagnostic products has been updated.
First misoprostol vaginal tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Report on the review of regulatory flexibilities/agilities as implemented by National Regulatory Authorities during Covid-19 pandemic
ID
IVD
IS
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VCP
See full report:
First dolutegravir 10mg dispersible 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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Ritonavir (WHOAPI-398) manufactured by Laurus Labs Limited has been prequalified by the WHO Prequalification Unit - Medicines Team (PQT/MED) under its API prequalification procedure.
Cipla’s paediatric ritonavir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
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New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
Addition under section:
Baricitinib and sotrovimab invited for COVID-19
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Baricitinib 2mg tablets and sotrovimab solution for infusion, 500 mg/8 mL (62.5 mg/mL) single use vial, invited for COVID-19.