Past News

Announcement

1 July, 2021 - 17:00 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Naari’s levonorgestrel tablet prequalified

Announcement

1 July, 2021 - 16:46 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Panpharma’s oxytocin injection prequalified

Announcement

1 July, 2021 - 16:45 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Tunggal’s medroxyprogesterone acetate depot injection prequalified

Announcement

1 July, 2021 - 16:30 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Macleods’ dispersible sulfadoxine/pyrimethamine tablet prequalified

Announcement

1 July, 2021 - 16:00 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

New Invitation for Expression of Interest (EOI) to manufacturers of antituberculosis medicines published

Announcement

29 June, 2021 - 21:00 (CEST)

The Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest for Product Evaluation to the WHO Prequalification Unit was recently updated following a request by

WHO Public Assessment Reports (WHOPARs) published

Announcement

29 June, 2021 - 10:51 (CEST)

WHO Public Assessment Reports (WHOPARs) published

Announcement

29 June, 2021 - 10:49 (CEST)

Two PQT Medicines workshops for manufacturers: The 4th Annual Quality Workshop for Manufacturers and the 1st Biotherapeutics Workshop for Manufacturers

Announcement

25 June, 2021 - 20:29 (CEST)

For further information see: /prequal/events/two-pqt-medicines-workshops-manufacturers

Summary Report of Preliminary Inspection Findings - Open Joint-Stock Company Pharmstandard - Ufa Vitamin Plant Ufa, Republic of Bashkortostan, Russia

Alerts

23 June, 2021 - 04:00 (CEST)

WHO Public Assessment Reports (WHOPARs) published

Announcement

2 June, 2021 - 18:06 (CEST)

WHO Public Assessment Reports (WHOPARs) published

Announcement

28 May, 2021 - 15:45 (CEST)

ICH Harmonised Guideline M9 “Biopharmaceutics Classification System-Based Biowaivers” implemented and updated biowaiver documentation published

Announcement

25 May, 2021 - 12:58 (CEST)

Effective 25 May 2021 the ICH guideline M9 “Biopharmaceutics Classification System-Based Biowaivers” is implemented by PQT/MED.

New WHO Public Assessment Report (WHOPAR) published

Announcement

24 May, 2021 - 17:08 (CEST)

Tocilizumab and sarilumab invited for COVID-19

Announcement

19 May, 2021 - 15:49 (CEST)

Tocilizumab and sarilumab invited for COVID-19.

New WHO Public Assessment Reports (WHOPARs) published

Announcement

14 May, 2021 - 11:12 (CEST)

New WHO Public Assessment Report (WHOPAR) published

Announcement

13 May, 2021 - 16:03 (CEST)

Macleods’ abacavir/lamivudine prequalified

Medicine Update

11 May, 2021 - 04:00 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

New WHO Public Assessment Reports (WHOPARs) published

Medicine Update

5 May, 2021 - 16:41 (CEST)

New WHO Public Assessment Report (WHOPAR) published

Announcement

23 April, 2021 - 16:36 (CEST)

Medopharm’s praziquantel prequalified

Announcement

22 April, 2021 - 04:00 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

New artesunate injection prequalified

Announcement

13 April, 2021 - 17:30 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Guilin’s artemether/lumefantrine dispersible tablets prequalified

Announcement

13 April, 2021 - 17:00 (CEST)

WHO Prequalification Unit (PQT) added the below new products to its prequalified list:

New WHO Public Assessment Report (WHOPAR) published

Announcement

12 April, 2021 - 19:28 (CEST)

S Kant’s SP dispersible tablet co-packed with amodiaquine dispersible tablet prequalified

Announcement

12 April, 2021 - 17:00 (CEST)

WHO Prequalification Unit (PQT) added the below new products to its prequalified list:

S Kant’s pyrimethamine/sulfadoxine dispersible tablets prequalified

Announcement

12 April, 2021 - 16:30 (CEST)

WHO Prequalification Unit (PQT) added the below new products to its prequalified list:

New WHO Public Assessment Report (WHOPAR) published

Announcement

9 April, 2021 - 17:33 (CEST)

New WHO Public Assessment Report (WHOPAR) published

Announcement

1 April, 2021 - 21:04 (CEST)

First albendazole prequalified

Announcement

1 April, 2021 - 12:30 (CEST)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

New WHO Public Assessment Reports (WHOPARs) published

Announcement

29 March, 2021 - 18:18 (CEST)

New WHO Public Assessment Reports (WHOPARs) published

Announcement

18 March, 2021 - 11:00 (CET)

Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes on inclusion of WHO Prequalification for TB in vitro diagnostics

IVD

Announcement

8 March, 2021 - 11:00 (CET)

The World Health Organization (WHO), through its Prequalification Unit and Global Tuberculosis Programme, would like to announce future changes to the WHO procedure to determine procurement eligibi

New WHO Public Assessment Report (WHOPAR) published

Medicine Update

8 March, 2021 - 10:00 (CET)

New WHO Public Assessment Reports (WHOPARs) published

Announcement

3 March, 2021 - 15:56 (CET)

Macleods’ 100mg isoniazid dispersible tablet prequalified

Announcement

2 March, 2021 - 15:31 (CET)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

First biosimilars prequalified after full assessment

Announcement

23 February, 2021 - 13:00 (CET)

WHO Prequalification Unit (PQT) added the below new products to its prequalified list:

New WHO Public Assessment Report (WHOPAR) published

Medicine Update

23 February, 2021 - 11:00 (CET)

Emcure’s dolutegravir/lamivudine/tenofovir tablet prequalified

Announcement

22 February, 2021 - 20:00 (CET)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Ipca’s sulfamethoxazole/trimethoprim prequalified

Medicine Update

17 February, 2021 - 16:00 (CET)

WHO Prequalification Unit (PQT) added the below new products to its prequalified list:

New WHO Public Assessment Reports (WHOPARs) published

Medicine Update

16 February, 2021 - 17:00 (CET)

New WHO Public Inspection Reports (WHOPIRs) published

Medicine Update

16 February, 2021 - 02:00 (CET)

IMPORTANT WITHDRAWAL NOTICE - AmBisome Liposomal Amphotericin B 50mg Powder for Concentrate for Dispersion for Infusion (HA705) - Minisart® Filter

Information note

12 February, 2021 - 02:00 (CET)

On 05 February 2021, Gilead Sciences Ltd.

Lab Leon Farma’s levonorgestrel prequalified

Announcement

5 February, 2021 - 02:00 (CET)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Gambia joins the collaborative registration procedure

Announcement

1 February, 2021 - 02:00 (CET)

Macleods’ sulfamethoxazole/trimethoprim prequalified

Announcement

28 January, 2021 - 02:00 (CET)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

New WHO Public Assessment Reports (WHOPARs) published

Announcement

27 January, 2021 - 16:00 (CET)

First dexamethasone and dexamethasone sodium phosphate Active Pharmaceutical Ingredients (APIs) prequalified

Announcement

27 January, 2021 - 15:30 (CET)

Dong-A’s clofazimine prequalified

Announcement

26 January, 2021 - 02:00 (CET)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

New WHO Public Assessment Reports (WHOPARs) published

Announcement

18 January, 2021 - 02:00 (CET)

Micro Labs dolutegravir prequalified

Medicine Update

6 January, 2021 - 02:00 (CET)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

First page
Previous page
…
2
3
4
5
6
7
8
9
10
…
Next page
Last page

Featured News

Request for Proposals: Review of cold chain equipment dossier submissions for prequalification

Please visit: https://www.ungm.org/Public/Notice/239857 

ePQS Freeze until July 17

As you might be aware, WHO has embarked on a project to streamline and improve the process of receiving submissions through the implementation of the ePQS (electronic Prequalification System). As part of the final phase of the implementation (integration between the ePQS system and a Document Management System), the system will be limited for daily operation from June 19th – July 17th 2024 . This will have internal implications that will slightly disrupt our normal operations. We will keep you informed as soon as full operation is restored. Even though this is a disruption, this will lead to a better and improved way of working for all of us in the near future. We appreciate your understanding in advance.

Request for Proposals: Support to the WHO Immunization and Equipment Pre-qualification Team

The WHO Immunization and Equipment Pre-qualification Team is seeking to enter into a contractual agreement with a successful bidder to implement the following work packages:   1.     Implementation of post market monitoring (PMM) of cold chain equipment project 2.     Assessment of new cold room technologies and support to standard setting 3.     Field testing of new technologies 4.     Investigation of technological solutions to problems caused by unstable mains power 5.     Authoring specifications and verification protocols for chemical indicators 6.     IT Helpdesk support to countries implementing PMM   WHO aims to select one or more Long Term Agreement (LTA) provider.   The Request for Proposals (RFP) is published on the United Nations Global Market website: https://www.ungm.org/Public/Notice/234522   To access this RFP, please register to the United Nations Global Marketplace (UNGM) at Basic level.   Please note that the full registration process must be completed to access the tender documents. Should you encounter difficulties, please consult registry@ungm.org.   Deadline: 24 May 2024   Organisation: WHO   Location: Various  

WHO to begin development of parallel recommendation and regulatory pathways; shortening the time taken for people to access health products

Ensuring access to quality-assured, safe and effective therapies is a core part of WHO’s mission. This involves two essential services: the development of recommendations on the use of important health products and, independently, their prequalification (PQ) or Emergency Use Listing (EUL). Health products include medicines, vaccines, medical devices including diagnostics and vector control products and may include other products based on future technology developments. Currently, recommendation development and PQ or EUL assessment occur sequentially. During the pandemic, WHO expedited the recommendation review and EUL of COVID-19 health products as parallel processes. This resulted in listing of the first antivirals several hours after the publication of their recommendations for use. What was an interim WHO process for the COVID-19 pandemic, will now be adopted for all products with the development of synchronized and parallel, but otherwise entirely independent processes. This will shorten time to access innovative health products in low / low-middle income countries.  Parallel processes will be triggered whenever WHO identifies the need to issue a new or revised recommendation. The target for the dual processes will be to complete both within twelve months from WHO’s initiation of the recommendation development process and formally accepting a manufacturer’s dossier for PQ or EUL assessment. The processes will conclude with a coordinated external communication of their outcome to the manufacturer and Member States.   Vitally, the integrity of the procedure will be maintained as the two processes remain fully independent and respect the confidentiality of manufacturers’ information as appropriate.  This new parallel process will improve access to essential and innovative health products and address inequities in countries that rely on WHO recommendations for the use of these products.  Links WHO PQ: Home | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) WHO EUL: https://www.who.int/teams/regulation-prequalification/eul    

Technical Specifications Series for WHO PQ of computer aided diagnosis of TB - for public comment (deadline 30 April 2024)

WHO Prequalification is inviting you to review the draft working document on Technical Specifications Series for submission to WHO Prequalification – Medical Device Assessment Screening and Triage of TB using Computer Aided Detection Software for Interpretation of Chest X-Ray Images (CAD for TB).   Deadline for submission of comments is 30 April, 2024 Please click this link to visit a page with more details.