Newly-prequalified active pharmaceutical ingredients (APIs)

News

17 August, 2016 - 02:00 (CEST)

Medicine Update

Lumefantrine manufactured by Micro Labs Ltd and Lopinavir manufactured by Acebright (India) Pharma Pvt Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.

WHOAPI-217 - Lumefantrine - Micro Labs Ltd - INDIA - FPPs containing lumefantrine are used in the therapeutic area of malaria
WHOAPI-258 - Lopinavir - Acebright (India) Pharma Pvt Ltd - INDIA - FPPs containing lopinavir are used in the therapeutic area of HIV/AIDS

Good-quality APIs are vital to the production of good-quality medicines. WHO prequalification of APIs will facilitate production of quality medicines by identifying such APIs for use by manufacturers of finished pharmaceutical products (FPPs).

API prequalification consists of a comprehensive evaluation procedure that has two components: assessment of the API master file (APIMF) to verify compliance with WHO norms and standards, and evaluation of the sites of API manufacture to verify compliance with WHO GMP requirements.

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.