WHO list of SARS-CoV-2 IVDs currently under assessment for Emergency Use Listing updated
IVD
News
Newly prequalified Active Pharmaceutical Ingredient (API)
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Nirmatrelvir (WHOAPI-458) manufactured by Z
First desogestrel 75 µg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First long-acting insulin analogues prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Swiss Pharma Nigeria’s dispersible zinc tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Cipla’s efavirenz/lamivudine/tenofovir 400/300/300mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PQT medicines will be at CPHi Shanghai - 19-21 June 2023
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The World Health Organization Prequalification Team - Medicines (PQT Medicines) will be attending the Shanghai SNIEC CPhi on 19-21 June 2023, in Shanghai, China.
Updated guidance on the development of zinc sulfate product dossiers for submission to PQT/MED
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Updated guidance on the development of zinc sulfate product dossiers for submission to PQT/MED has been posted to the PQT/MED website.
Dr Reddy’s molnupiravir 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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Ethionamide (WHOAPI-422) manufactured by Micro Labs Limited, has
New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
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The following API was added:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Oseltamivir (phosphate) (WHOAPI-421) manufactured by Shanghai Desano Chemical Pharmaceu
1st Invitation to manufacturers of medicinal products for treatment of multi-drug resistant bacterial infections, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
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A 1st Invitation for Expression of Interest (EOI) for treatment of multi-drug resistant bacterial infections has been published by the WHO Prequalification Unit - Medicines Assessment Team (PQT/MED
Two PQT Medicines trainings for regulators in 2023
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The 15th Annual Prequalification Team: Medicines (PQT/MED) Quality Assessment Training will be a virtual workshop that will take place on Monday, 5 June through Thursday, 8 June 2023.
Bial’s misoprostol vaginal tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO Collaborative Registration Procedure – Update for IVD Manufacturers
IVD
The PQ IVD Assessment Team held a virtual Workshop on the 15th of March with in vitro diagnostic (IVD) manufacturers to provide an update on implementation of the Collaborative Registration Procedu
First benzyl penicillins prequalified. For treatment of maternal syphilis and prevention of congenital syphilis.
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list: