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  • Regulatory NewsRegulatory News

    WHO Releases First Guideline on Digital Health Interventions

    The World Health Organization (WHO) on Wednesday released a first-of-its-kind guideline on 10 ways for countries to apply digital health interventions across the health system while avoiding potential detrimental effects. The 10 recommendations are detailed in the UN agency’s 124-page guideline for strengthening health systems through the appropriate implementation of digital health. The focus of the guideline is currently limited to digital health technologies that can...
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    WHO Drafts Global Strategy on Digital Health

    The World Health Organization (WHO) released a newly drafted four-year global strategy on digital health, with an aim to “improve health for everyone, everywhere by accelerating the adoption of appropriate digital health.” As more health care delivery systems look to digital health to address emerging challenges, such as the rise of noncommunicable diseases, clinician workforce shortages and the aging population, barriers to the adoption and application of such tools pe...
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    WHO Advances International Harmonized Nomenclature for Medical Devices

    The World Health Organization (WHO) reported Monday on recent progress toward the development of its international nomenclature for medical devices, known as the International Classification of Medical Devices (ICMD). WHO discussed work in progress at the 4th Global Forum on Medical Devices, which took place last December. “Having a nomenclature system in place for medical devices facilitates their management and regulation by standardizing terms that enable communic...
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    WHO Finds Wide Disparities in Antibiotic Use Between Countries

    A new report from the World Health Organization (WHO) published Monday reveals major differences in the amount of antibiotics consumed by countries around the world and calls for changes in how countries monitor and use antimicrobial drugs.   “Overuse and misuse of antibiotics are the leading causes of antimicrobial resistance. Without effective antibiotics and other antimicrobials, we will lose our ability to treat common infections like pneumonia,” said Suzanne Hill,...
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    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 ...
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    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...
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    WHO to Craft Essential Diagnostics List

    The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL). The committee said the decision to begin developing such a list, agreed to earlier this month, may initially focus on in vitro diagnostics, with initial proposed priority areas including tuberculosis, malaria, HIV and hepatitis B and C. According to WHO , the list "should expand to other areas including other antimicrobial...
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    Caribbean Regulatory System Begins Recommending Generic Drugs

    The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments. The recommendations, which follow approval from WHO, included emtricitabine/tenofovir and tenofovir tablets, also known as generic versions of Viread and Truvada (a generic of which also recently won US FDA approval ). The regional initiative is meant to help ...
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    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, ...
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    WHO Elects First African Director-General

    The World Health Organization (WHO) on Tuesday announced that Dr. Tedros Adhanom Ghebreyesus of Ethiopia has been elected by member states as the new Director-General of WHO. Nominated by the Ethiopian government, he will begin his five-year term on 1 July 2017 and succeed Dr. Margaret Chan, who has been Director-General since January 2007. Chan addressed the 70th World Health Assembly on Monday, noting the challenges that lay ahead for the agency. Ghebreye...
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    WHO Officials Offer Opposition to Value-Based Drug Pricing

    World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing. "What’s the value of life? This structure is good for luxury goods because you have a choice…if I’m sick with cancer, what’s the choice? We think value-based pricing is not feasible for products that are indispensable," Dr. Marie-Paule Kieny, assistant director-general of health systems and innovation at WH...
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    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...