WHO list of SARS-CoV-2 IVDs currently under assessment for Emergency Use Listing updated
IVD
News
Cipla’s abacavir/lamivudine prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Request for Proposals (RFP) - Post Market Monitoring Country Technical Support to WHO Immunization and Equipment Prequalification Team
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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 support up to 5 countries to implement Post Mar
Request for Proposals (RFP) - Solar Direct Drive Walk-in Cold & Freezer Rooms Field Evaluation
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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 following work: to implement a tw
Request for Proposals (RFP) - Technical Assistance to WHO Immunization and Equipment Prequalification Team
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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 following work: Vaccines & Im
New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
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The following API was added:
- APIs for antimalarial medicinal products
- Quinine (hydrochloride)
WHO IVD PQ and EUL Ukraine Workshop
IVD
In partnership with the European Regional Office and WHO Country Office in Ukraine the PQ IVD Assessment Team held a virtual Workshop on the 10th of February with regulators from the National Regul
New 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.
Janssen’s darunavir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
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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IVD
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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: