WHO list of SARS-CoV-2 IVDs currently under assessment for Emergency Use Listing updated
IVD
News
New Ag RDT added to WHO EUL listing
IVD
On 18 July 2022 the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was added to WHO EUL listing.
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.
Desano’s efavirenz/lamivudine/tenofovir tablets prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredients (APIs)
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Pyronaridine (phosphate) (non-micronised: WHOAPI-405a and micronised: WHOAPI-405b) manufactured by Mangalam Drugs & Organics Ltd has been prequalified by the WHO Prequalification Unit - Medicin
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.
Mylan’s Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
SAVE THE DATE - Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers
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On behalf of the United Nations Children Fund (UNICEF), the United Nations Population Fund (UNFPA) and the World Health Organization (WHO), we invite you to save the date for the 2022 Joint UNICEF-
Request for Proposals - Establishment of a WHO PQ technical evaluation specifications and protocols for the performance evaluation of computer-aided detection software for tuberculosis and other medical devices
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The purpose of this Request for Proposals (RFP) is to identify a suitable contractor to establish a WHO PQ technical evaluation specifications and protocols for the performance evaluation of comput
Invitation to Laboratories to Submit an Expression of Interest in Becoming a Performance Evaluation Laboratory for TB Nucleic Acid Tests
IVD
Laboratories with experience in conducting independent performance evaluation of in vitro diagnostics (IVDs) are invited to submit an Expression of Interest (EOI) to become a Performance Evaluation
New Performance Evaluation Laboratories
IVD
Two laboratories were added to the list of Performance Evaluation Laboratories (PEL) :
First carbetocin prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
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.
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 s
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: