News

On 07 April 2017, WHO issued a position paper on the import alert placed on, Qinhuangdao Zizhu Pharmaceutical (QZP) by the United States Food and Drug Administration (USFDA) on 8 March 2017.

New WHO Public Assessment Report (WHOPAR) published

Medicine Update

13 February, 2018 - 02:00 (CET)

New WHO Public Assessment Reports (WHOPARs) published

Medicine Update

8 February, 2018 - 02:00 (CET)

Hetero’s sofosbuvir tablet prequalified

Announcement

7 February, 2018 - 02:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

New WHO Public Inspection Reports (WHOPIRs) published

Medicine Update

6 February, 2018 - 02:00 (CET)

New WHO Public Assessment Report (WHOPAR) published

Medicine Update

5 February, 2018 - 02:00 (CET)

Notice of Concern (NOC) withdrawn for Svizera Labs Pvt Ltd

Announcement

1 February, 2018 - 02:00 (CET)

Following corrective actions taken by Svizera Labs Pvt Ltd and the clarifications provided

New WHO Public Assessment Reports (WHOPARs) published

Medicine Update

31 January, 2018 - 02:00 (CET)

New WHO Public Inspection Reports (WHOPIRs) published

Medicine Update

25 January, 2018 - 02:00 (CET)

New WHO Public Assessment Reports (WHOPARs) published

Medicine Update

24 January, 2018 - 02:00 (CET)

Newly prequalified Active Pharmaceutical Ingredients (APIs)

Announcement

11 January, 2018 - 02:00 (CET)

New WHO Public Inspection Reports (WHOPIRs) published

Medicine Update

21 December, 2017 - 02:00 (CET)

Newly prequalified Active Pharmaceutical Ingredient (API)

Announcement

15 December, 2017 - 02:00 (CET)

Linezolid manufactured by Optimus Drugs Pvt Ltd has been

Temmler Pharma’s ethinylestradiol/levonorgestrel tablet prequalified

Announcement

12 December, 2017 - 09:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Hetero’s aciclovir tablet prequalified

Announcement

12 December, 2017 - 08:30 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Aurum Pharmaceuticals' magnesium sulfate injection prequalified

Announcement

12 December, 2017 - 08:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:

Mylan’s cycloserine capsules prequalified

Announcement

12 December, 2017 - 07:30 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Mylan’s capreomycin injection prequalified

Announcement

12 December, 2017 - 07:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Shanghai Desano’s efavirenz tablet prequalified

Announcement

12 December, 2017 - 06:30 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Macleods’ linezolid tablet prequalified

Announcement

12 December, 2017 - 06:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Macleods’ paediatric rifampicin/isoniazid/pyrazinamide dispersible tablet prequalified

Announcement

12 December, 2017 - 05:30 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Strides Shasun's artemether/lumefantrine dispersible tablet prequalified

Announcement

12 December, 2017 - 05:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Laurus' tenofovir tablet prequalified

Announcement

12 December, 2017 - 04:30 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

New WHO Public Assessment Reports (WHOPARs) published

Announcement

12 December, 2017 - 04:00 (CET)

First entecavir prequalified

Announcement

29 November, 2017 - 16:30 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

First terizidone prequalified

Announcement

29 November, 2017 - 16:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Pfizer’s medroxyprogesterone acetate 104mg/0.65mL suspension for injection (Sayana® Press) prequalified

Announcement

29 November, 2017 - 15:30 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

Hetero's abacavir/lamivudine tablet prequalified

Announcement

29 November, 2017 - 15:00 (CET)

WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:

New WHO Public Inspection Report (WHOPIR) published

Medicine Update

29 November, 2017 - 02:00 (CET)

Newly prequalified Active Pharmaceutical Ingredient (API)

28 November, 2017 - 11:00 (CET)

Atazanavir (sulfate) manufactured by Macleods Pharmaceuticals Ltd has been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

New WHO Public Assessment Reports (WHOPARs) published

Medicine Update

28 November, 2017 - 10:00 (CET)

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.