First long-acting insulin analogues prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
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
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
Request for Proposals (RFP) - WHO Prequalification website maintenance and support
ID
IVD
IS
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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
First human insulins prequalified
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The first human insulins have been prequalified by WHO: fast-acting human insulin 100 IU/ml and intermediate-acting human insulin 100 IU/ml from Novo Nordisk A/S.
1st Invitation to manufacturers of IVDs medical devices used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis to apply for WHO prequalification assessment as of 22 September
IVD
To support the global effort to end the TB epidemic, through the provision of guidance to interested United Nations (UN) and other agencies and WHO Member States in their procurement decisions,
WHO issues its first emergency use listing for a SARS-CoV-2 self-test
IVD
Today, WHO listed the first quality-assured SARS-CoV-2 self-test for emergency use.
Nitrosamine concerns in rifapentine products - Update
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As previously announced, the nitrosamine impurity, 1-cyclopentyl-4-nitrosopiperazine (CPNP), has been identified in rifapentine products.
The EOI for human insulin now revised to include long-acting insulin analogues
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The changes to the EOI for human insulin shown below in bold and italic