List of IVDs that were not accepted under WHO Emergency Use Listing for SARS-CoV-2 updated
IVD
News
EPQs email account notification
IVD
As of 2023 the WHO Prequalification Team has started using the ePQS platform (Salesforce cloud-based software) to manage application submissions and workflow.
Special announcement to manufacturers regarding Malaria RDTs
IVD
We have been receiving applications from several manufacturers of malaria RDTs, either as new product applications or as Change Requests, regarding the inclusion single-test configurations in their
ICH Harmonised Guideline M10 Bioanalytical Method Validation and Study Sample Analysis to be implemented by PQT/MED
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The recent ICH Harmonised Guideline M10 Bioanalytical Method Validation and Study Sample Analysis, adopted by ICH 24 May 2022, will be implemented by PQT/MED effective 1 May 2023
Newly prequalified Active Pharmaceutical Ingredient (API)
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Flucytosine (WHOAPI-406) manufactured by Solara Active Pharma Sciences Limited, has been prequalified by the
Request for Proposals (RFP) - WHO Prequalification website maintenance and support
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VCP
The purpose of this Request for Proposals (RFP) is to enter into a contractual agreement with a successful bidder and select a suitable contractor to carry out the maintenance and support of the ev
Celltrion’s efavirenz/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Emcure’s molnupiravir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First nirmatrelvir + ritonavir generic prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Variation application form and FAQ Variation document updated
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WHO Prequalification Team – Medicines (PQT/MED) updated the variation application form and FAQ variation document:
PRESENTATIONS NOW AVAILABLE - Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers
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The 2022 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers took place from 28 November to 1 December 2022 at UN City, Marmorvej 51, 2100 Copenhagen,
HLL Lifecare’s ethinylestradiol/levonorgestrel prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s dolutegravir/lamivudine/tenofovir 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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Aabcavir (sulfate) (WHOAPI-377) manufactured by Jiangsu Weiqida Pharmaceutical Co Ltd, has been prequalified by the WHO Prequalific
First delamanid prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Desano’s efavirenz/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First paediatric linezolid prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list: