Recent Highlights - IVD
IVD
Between 1 March and 16 April 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product l
News
Call for Experts – Roster of Consultant for WHO Medical Device Prequalification
IVD
The WHO Prequalification Unit is expanding its scope and is establishing a roster of consultants to s
A significant milestone in the fight against malaria
IVD
WHO Prequalification has listed three malaria rapid diagnostic tests:
2026 IVD Assessment Sessions
IVD
In 2026 more frequent dossier assessment sessions have been planned to facilitate timely review of IVD product dossiers and corrective
Active Pharmaceutical Ingredient (API) Prequalified
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Lamivudine manufactured by Arene Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Active Pharmaceutical Ingredient (API) Prequalified
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Tenofovir disoproxil fumarate manufactured by SMS Pharmaceuticals Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Request for Quotations (RFQ) - WHO Prequalification Assessment for Medical Device
IVD
The purpose of this Request for Quotations (RFQ) is to enter into a contractual agreement with a successful bidder and select a suitabl
Microlab’s Abacavir (as sulfate)/Dolutegravir (as sodium)/Lamivudine Dispersible Tablet, 60 mg/5 mg/30 mg prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Expansion of the Insulin Master File Procedure to Insulin Analogues
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Access to affordable insulin remains a critical public health priority.
Mylan’s Bedaquiline 100mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified l
Renata’s Ethinylestradiol/Levonorgestrel 30µg/150µg Tablet, with Ferrous Fumarate Tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified l
Lupin’s Isoniazid 100mg dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified l
This week (23-27 March 2026), the Prequalification Medicines Team is conducting its 150th Medicines Assessment Session
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The journey began 25 years ago in 2001 with the guiding motto “working for countries, with countries,” marked by the convening
Active Pharmaceutical Ingredient (API) Prequalified
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Darunavir (ethanolate) manufactured by Arene Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Active Pharmaceutical Ingredient (API) Prequalified
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Desogestrel (WHOAPI-479) manufactured by Hunan KYF Pharmaceutical Co. Ltd. has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
24th Invitation to Manufacturers of Antimalarial Medicines to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit (PQT)
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The invitation to Manufacturers of Antimalarial Medicines to submit an Expre
23rd Invitation to Manufacturers of Antituberculosis Medicines to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit
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The Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interes
Active Pharmaceutical Ingredient (API) Prequalified
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Lamivudine, manufactured by SMS Pharmaceuticals Limited, has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Post PQ Change Request for Prequalified & EUL-listed IVDs Process & Guidance Feedback Survey
IVD
The survey on the updated Post PQ Change Request process and PQDx 121 guidance shows that manufacturers are broadly satisfied with recent improvements to the system.
Active Pharmaceutical Ingredient (API) Prequalified
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WHOAPI-429 (tenofovir disoproxil fumarate) manufactured by Styrax Pharma Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Position Note on Accessories Published
IVD
A Position Note on Accessories has been published by the Assessment of Medical Devices Team.
New WHO Public Inspection Reports (WHOPIRs) Published
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New WHO Public Inspection Reports (WHOPIRs) were published today:
Amended invitation to manufacturers of Monkeypox virus IVDs published
IVD
On 11 February 2026 WHO published an amended invitation to manufacturers of Monkeypox virus IVDs
ePQS Mandatory Use announced – 11 May 2026
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The ePQS Portal is the externally-facing Salesforce Community site of the WHO Prequalification Unit’s new ePQS system.
New measles stand-alone vaccine prequalified
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WHO has added the Measles Vaccine (Live) (Attenuated, Freeze-Dried) to its list of prequalified vaccines
New WHO Public Inspection Reports (WHOPIRs) Published
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New WHO Public Inspection Reports (WHOPIRs) were published today:
Survey on change requests assessment by WHO
IVD
This survey aims to gather feedback on the updated PQDx 121 guidance, the new change request submission form, and the overall submission and assessment process.
Invitation to submit applications for WHO’s prequalification assessment
IVD
WHO is pleased to announce that the Prequalification of IVDs programme scope has been expanded to the following types of products:
New IVD prequalification listing
IVD
On 18th December the Loopamp MTBC Detection Kit manufactured by Eiken Chemical Co., Ltd. was prequalified.
Notice of Concern (NOC) for Meril Diagnostics Pvt Ltd Published
IVD
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A Notice of Concern (NOC) has been published by the World Health Organization (WHO), through its Prequalification Unit (PQT), for Meril Diagnostics Pvt Ltd.
Rusan’s azithromycin tabl and Ipca’s albendazole tabl prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Active Pharmaceutical Ingredient (API) Prequalified
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Levonorgestrel manufactured by Jiangsu Lianhuan Pharmaceutical Co., Ltd.
Notice on Fee Adjustments for the WHO Prequalification Programme
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Effective 1 January 2026, the WHO Prequalification Programme will introduce an annual 10% increase on all applicable fees that have remained unchanged since 2017.
First EUL to PQ transition of IVDs
IVD
For the first time, two SARS-CoV-2 antigen detection rapid tests have successfully transitioned from WHO’s Emergency Use Listing (EUL) to WHO Prequalification (PQ):
WHO webinar on changes to the PQ procedure for IVDs - 17 Dec 2025
IVD
On 17 December 2025 the Assessment of Medical Devices Team held a webinar for stakeholders to introduce changes which will be implemented to the prequalification assessment
WHO Prequalification Workshop for Chinese manufacturers of IVDs - Guangzhou 9-11 December 2025
IVD
WHO recently hosted a successful workshop in The Westin Guangzhou, Guangzhou, China, bringing together over
Emergency Use Listing of the 12th MPXV assay
IVD
The Monkeypox Virus (MPXV) Fast Real Time PCR Kit manufactured by Jiangsu Bioperfectus Technologies Co., Ltd.
First caffeine products for apnoea in pre-term infants prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
23nd Invitation to Manufacturers of Antimalarial Medicines to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit (PQT)
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The invitation to Manufacturers of Antimalarial Medicines to submit an Expression of Interest for Product Evaluation to t