Search Results for WHO prequalification

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WHO to Launch Pilot to Prequalify Biosimilars By Zachary Brennan - Published 05 September 2017

The World Health Organization (WHO) announced Tuesday that in October it will launch a pilot project for prequalifying biosimilars as part of its work to make some of the most expensive treatments for cancer more widely available in low- and middle-income countries.

Categories: News, WHO, Biologics and biotechnology, Drugs

Tags: biosimilar prequalification, WHO prequalification

WHO Drafts New Prequalification Timeline, KPIs By Zachary Brennan - Published 07 August 2017

As part of efforts to better monitor and improve the performance of its prequalification program, the World Health Organization (WHO) has proposed a new algorithm to calculate the prequalification timeline and drafted new key performance indicators (KPIs) to track. 

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Drugs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: WHO prequalification

WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns By Michael Mezher - Published 02 June 2017

The World Health Organization Prequalification Team (WHO-PQT) said this week that it is no longer concerned about the quality of prequalified products made at Mylan Pharmaceuticals' Nashik, India site after the US Food and Drug Administration (FDA) warned the site over quality system issues in April.

Categories: News, India, FDA, WHO, Drugs

Tags: WHO Prequalification, Mylan, Nashik

WHO Prequalifies First Hepatitis C Diagnostic By Zachary Brennan - Published 05 December 2016

The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Government affairs, In vitro diagnostics, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: WHO, prequalification, Gilead, Hepatitis C

WHO Seeks API Manufacturers for Prequalification Program By Zachary Brennan - Published 10 October 2016

The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, ICH, WHO, Active pharmaceutical ingredients, Crisis management, Due Diligence, Government affairs, Manufacturing

Tags: WHO prequalification program, API manufacturing, ICH, regulatory authorities and WHO

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable By Zachary Brennan - Published 30 September 2016

The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: WHO, prequalification of vaccines, prequalification of medicines, WHO funds