Collaborative Registration Procedure (CRP) Workshops
IVD
Two virtual CRP Advocacy and Sensitization Workshops were held in partnership with WHO Regional Offices: PAHO-AFRO 8-10 June 2022 and EMRO-SEARO-WPRO 14-16 June 2022.
News
Emergency Use Listing (EUL) Workshop
IVD
In partnership with the WHO Country Office in Turkey the PQ Team held an EUL Workshop on the 28 April 2022 with IVD regulators from the national regulatory authority TITCK and IVD manufacturers bas
PQ Guidance documents
IVD
Continuing its efforts to support prequalification applicants and increase transparency, PQT has started developing Technical Specifications for glucose meters and HbA1c POC IVDs.
COVID-19 Pandemic and Emergency Use Listing (EUL)
IVD
Emergency Use Listing (EUL) for candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 remains ongoing. WHO has expanded the scope of EUL to include SARS-CoV-2 AgRDTs intended for self-testin
Hetero’s efavirenz/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ efavirenz/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
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
First isoniazid/rifapentine generic prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s cycloserine capsule prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Macleods’ pyridoxine tablets prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Publication of the Second Edition of the Manual on development and use of FAO and WHO specifications for chemical pesticides
VCP
WHO and FAO are pleased to announce the publication of the second edition of the Manual on development and use of FAO and WHO specifications for chemical pesticides.
Atazanavir/ritonavir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Trastuzumab 440mg co-packed with bacteriostatic water for injection for multiple dosing prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Paediatric dispersible abacavir/lamivudine tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ dolutegravir/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Withdrawal of Vector Control TC products and the corresponding reference profiles supporting WHO Specifications
VCP
Recently, seven active ingredient Technical Material (TC) products, previously evaluated by WHO, were withdrawn by the recognized applicants. In so doing, the applicants
ITN Product Review Report
VCP
WHO PQT/VCP recently published the following report - Product Review Report - Insecticide Treated Nets Formulated with Pyrethroid+PBO and Pyrethroid+2nd Ac
Gilead’s remdesivir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First nirmatrelvir + ritonavir prequalified for Covid-19
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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