WHO lists the first BDBV test under its EUL procedure
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IVD
News
New addition to WHO's list of prequalified IVDs: Determine™ Syphilis Advanced
IVD
WHO has prequalified the Determine™ Syphilis Advanced
Active Pharmaceutical Ingredient (API) Prequalified
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Dolutegravir (sodium) manufactured by M/s.
WHO's Public Assessment Reports (WHOPAR) Update
IVD
Between 27 May and 19 June 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product labelling, documentation, and other relevant post-prequa
Update on EUL for Bundibugyo Virus IVDs
IVD
WHO has published an update on the status of ongoing Emergency Use Listing (EUL) applications for in vitro diagnostics (IVDs) for Bundibugyo virus disease (BDBV).
Mepro’s Praziquantel tablet Prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Dolutegravir tablets manufactured by RV Life Sciences Prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Hetero’s Darunavir (ethanolate)/Ritonavir, FDC tablets prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
PQT medicines will be at CPHi Shanghai - 16-18 June 2026
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The World Health Organization Prequalification Teams - Medicines Assessment and Inspections - will be attending the Shanghai SNIEC CPhi on 16-18 June 2026, in Shanghai, China.
Prequalification workshop for manufacturers of IVDs
IVD
A WHO workshop brought together manufacturers of IVDs, to advance access to quality-assured diagnostics, with a focus on strengthening understanding of prequalification req
Call for public consultation – WHO’s Procedure for prequalification of vaccines
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The World Health Organization (WHO), through its Department of Regulation and Prequalification, provides guidance to the United Nations Children’s Fund, other interested United Nations agencies, Me
EUL for IVDs – Bundibugyo virus (BDBV) nucleic acid detection
IVD
WHO has published detailed submission instructions for the Emergency Use Listing (EUL) of in vitro diagnostics for Bundibugyo virus disease (BDBV)
WHO's Public Assessment Reports (WHOPAR) Update 17 April to 27 May 2026
IVD
Between 17 April and 27 May 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product labelling, documentation, and other relevant post-prequ
41st Invitation of Active Pharmaceutical Ingredients (APIs)
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The following APIs were added:
1st Invitation to manufacturers of medicinal products for treatment of substance use disorders, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
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The 1st Invitation to manufacturers of medicinal products for treatment of substance use disorders to submit an application for product evaluation by prequalification has been issued based on a req
3rd Invitation to Manufacturers of medicinal products for management of diabetes to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit
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The Invitation to Manufacturers of human insulin and insulin analogues was recently updated and renamed as Invitation to Manufacturers of medicinal products for management of diabetes to Submit an
Active Pharmaceutical Ingredient (API) Prequalified
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Amodiaquine (hydrochloride) manufactured by Anuh Pharma Ltd. has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Active Pharmaceutical Ingredient (API) Prequalified
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WHOAPI-431 (Albendazole) manufactured by Rakshit Drugs Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
WHO Prequalification of cobas® MTB‑RIF/INH
IVD
WHO has prequalified the cobas® MTB‑RIF/INH assay, confirming its compliance with international quality, safety, and performance requirements under the WHO Prequalification progra
Training of Assessors for IVD Prequalification in WHO Academy, Lyon, France
IVD
A training for assessors is being conducted at the WHO Academy in Lyon from 21 to 24 April 2026 to strengthen capacity for the WHO prequalification of in vitro diagnostics (IVDs).
New prequalification listing of a TB NAT assay
IVD
The cobas® MTB test by Roche Diagnostics has been added to the WHO Prequalification list, supporting access to quality‑assured molecular tuberculosis diagnostics.
WHO Prequalification Workshop for IVD Manufacturers, WHO Geneva, 8 to 10 June 2026
IVD
WHO will hold a Prequalification Workshop for manufacturers of in vitro diagnostics (IVDs) from 8–10 June 2026 at WHO headquarters in Geneva.
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
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