• Regulatory NewsRegulatory News

    WHO to Launch Pilot to Prequalify Biosimilars

    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. The first "Expression of Interest," according to WHO, will cover both rituximab (Roche’s Rituxan) and trastuzumab (Roche’s Herceptin), and will be published in October 2017. In Europe, there are five ...
  • Regulatory NewsRegulatory News

    WHO Drafts New Prequalification Timeline, KPIs

    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.  Background Each year, billions of dollars are spent on medicines by international procurement agencies for distribution in resource-limited countries. WHO’s prequalification of medicines is a service to...
  • Regulatory NewsRegulatory News

    WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns

    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. Background FDA's warning letter raised fears that a suspension of production at the site, which produces 21 WHO-prequalified antiretroviral drugs used to treat HIV/AIDs, ...
  • Regulatory NewsRegulatory News

    Challenges Providing Pharmaceutical Products to Syrian Refugees

    This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality. Introduction Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have wor...
  • Regulatory NewsRegulatory News

    WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall

    The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries. The two cancer treatments—Roche's Rituxan (rituximab) and Herceptin (trastuzumab)—make the top ten list for highest grossing drugs worldwide and cost in the tens of thousands of dollars pe...
  • Regulatory NewsRegulatory News

    WHO Prequalifies First Hepatitis C Diagnostic

    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. The prequalification of South Korea-based Standard Diagnostics’ point-of-care diagnostic, called SD BIOLINE HCV, comes as an increasing number of people in low- and middle-income countries are now gaining access to hepatitis C cure...
  • Regulatory NewsRegulatory News

    WHO Seeks API Manufacturers for Prequalification Program

    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. WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of...
  • Regulatory NewsRegulatory News

    WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

    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. The new fees will also include the setting (and public disclosure) of quantitative performance targets. Indicators and performance targets will relate to review time for full assessment, review time for abbreviate...
  • Regulatory NewsRegulatory News

    FDA’s CBER to Forge Stronger Ties With WHO

    The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards. FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as w...
  • Regulatory NewsRegulatory News

    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...