Newly prequalified Active Pharmaceutical Ingredients (APIs)

News

1 February, 2019 - 02:00 (CET)

Raltegravir (potassium) (WHOAPI-326) manufactured by Mylan Laboratories Ltd and dolutegravir (sodium) (WHOAPI-325) manufactured by Laurus Labs Ltd have been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

WHOAPI-325 - Dolutegravir (sodium) - Laurus Labs Ltd - INDIA
- FPPs containing dolutegravir (sodium) are used in the therapeutic area of HIV/AIDS

WHOAPI-326 - Raltegravir (potassium) - Mylan Laboratories Ltd - INDIA - This is the first raltegravir (potassium) API to be prequalified
- FPPs containing raltegravir (potassium) 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 facilitates 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 Good Manufacturing Practice requirements.

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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.

16 November, 2023 - 11:00 (CET)

First products for Ebola Virus Disease prequalified

WHO Prequalification Unit (PQT) added the below new products to its prequalified list: BT-EB001 - Atoltivimab/Maftivimab/Odesivimab - 16.67mg/mL/16.67mg/mL/16.67mg/mL - Solution for infusion - Regeneron Pharmaceuticals Inc - UNITED STATES   BT-EB002 - Atoltivimab/Maftivimab/Odesivimab - 33.33mg/mL/33.33mg/mL/33.33mg/mL - Solution for infusion - Regeneron Pharmaceuticals Inc - UNITED STATES