FAQs and Key Updates on the New Change Request Process for Prequalified and EUL IVDs
IVD
News
First eCTD application for Active Pharmaceutical Ingredient (API) Prequalification received at WHO PQT via the ePQS Portal
M
The WHO Prequalification Unit (PQT) is pleased to announce the successful submission of its first eCTD formatted dossier for API Prequalification via the recently opened ePQS Portal.
First eCTD application received at WHO PQT via the ePQS Portal
ID
IVD
IS
M
V
VCP
The WHO Prequalification Unit is pleased to announce the successful submission of its first eCTD formatted dossier via the recently opened ePQS Portal.
Two PQT Medicines trainings for regulators
M
The PQT Medicines Annual Quality Assessment Training for regulators will take place from 9 to 12 June 2025.
Active Pharmaceutical Ingredient (API) Prequalified
M
Rifampicin (WHOAPI-520) manufactured by Hebei Xingang Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Virtual meeting held with Prequalification of IVDs PELs
IVD
A virtual meeting of Performance Evaluation Laboratories (PELs) was organized on 28 May 2025 to introduce the new procedure for WHO’s performance evaluation of in vitro diag
Expanded reliance mechanisms
M
PQT/MED currently has two major prequalification pathways – the full assessment pathway for generics not approved by a Stringent Regulatory A
Two additional MPXV tests listed by WHO under the Emergency Use Listing procedure
IVD
We are pleased to announce that two additional MPXV tests have been listed under WHO's Emergency use listin
The WHO Prequalification Unit is pleased to announce the opening of the ePQS portal to external users
ID
IVD
IS
M
V
VCP
The WHO Prequalification (PQT) Unit is pleased to announce the opening of the ePQS portal to external users on 19 May 2025.
Join us for Informative webinar on the latest new WHO guidance on reportable changes to WHO PQ and EUL IVDs_19 May 2025
IVD
Dear colleagues,
You are invited to a Zoom webinar.
An additional HIV RDT was prequalified by WHO
IVD
The professional use only version of
WHO prequalified the first HIV-1 self-test by Urine
IVD
The WANTAI HIV SELF TEST BY URINE Rapid Urine Test for Detection of Antibody to Human Immunodeficiency Vir
Publication of updated Guidance and Application Form for Reportable changes to WHO prequalified and emergency use listed in vitro diagnostics
IVD
WHO is pleased to announce the publication of the revised guidan
Prequalification of IVDs scope expanded to haemoglobin PoC analysers
IVD
WHO is pleased to announce that the Prequalification of in vitro diagnostics programme has been expanded to point-of-care analysers intended for:
Active Pharmaceutical Ingredient (API) Prequalified
M
Dolutegravir (sodium) manufactured by Styrax Pharma Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
A new HPV assay prequalified by WHO
IVD
On 27 March WHO prequalified one additional in vitro diagnostic, the
Information on the GMP status of Mylan Laboratories Ltd (Viatris, Inc.) manufacturing facility situated at Indore, Pithampur (Madhya Pradesh, India)
IS
WHO Prequalification Inspection Services performed an on-site for-cause inspection on Mylan’s Pithampur manufacturing site from 3 to 7 March 2025.
Active Pharmaceutical Ingredient (API) Prequalified
M
Nirmatrelvir manufactured by DongBang Future Tech & Life Co., Ltd.
PQT/MED: Expanded abridged prequalification pathways
M
According to WHO’s Procedure for prequalification of pharmaceutical products (TRS 961, Annex 10), “WHO recognizes the evaluation of relevant
38th Invitation of Active Pharmaceutical Ingredients (APIs)
M
The following API was added:
Lupin’s ethambutol 100 mg dispersible prequalified
M
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
S Kant’s pyridoxine 10 mg tabl prequalified
M
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PQT/MED publishes first invitation to manufacturers of medicinal products for treatment of bacterial infections in children to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
M
A first invitation to manufacturers of medicinal products for treatment of bacterial infections in children, to submit an Expression of Interest (EOI) for product evaluation has been published by t
RV Lifesciences’ entecavir products prequalified
M
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
PQT/MED publishes first invitation to manufacturers of Mycobacterium tuberculosis antigen-based skin tests (TBSTs) to submit an Expression of Interest (EOI)
M
A first invitation to manufacturers of Mycobacterium tuberculosis antigen-based skin tests (TBSTs), to submit an Expression of Interest (EOI) for product evaluation has been published by the WHO Pr
Active Pharmaceutical Ingredient (API) Prequalified
M
Albendazole (WHOAPI-427) manufactured by Sequent Scientific Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Medopharm’s chewable albendazole tabl prequalified
M
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
- NT012 Albendazole Tablets, Chewable 400mg – Medopharm - INDIA
Active Pharmaceutical Ingredient (API) Prequalified
M
Dihydroartemisinin manufactured by Guilin Pharmaceutical Co., Ltd.
MSN Laboratories’ bedaquiline tabl prequalified
M
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
TB395 Bedaquiline fumarate Tablet 100mg - MSN Lab - INDIA
Mylan’s nirmatrelvir + ritonavir tabl prequalified
M
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Guilin’s 120 and 180 mg powder for sol for inj prequalified
M
WHO Prequalification Unit (PQT) added the below new products to its prequalified list: