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  • Regulatory NewsRegulatory News

    WHO ACT-Accelerator prioritizes global vaccine approach

    The importance of a global approach to vaccine development and production, with a focus on collaboration, was a topic of a technical update and press briefing held 26 June by the World Health Organization (WHO).   The usual practices for drug development have been upended by the speed and scale of the COVID-19 pandemic, said officials. “I’m very hopeful and optimistic that this will be an unprecedented collaboration that also sets a model for the future,” said WHO Chie...
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    Rituximab biosimilar prequalified by WHO

    The World Health Organization (WHO) has prequalified South Korean drugmaker Celltrion’s biosimilar version of rituximab, the second product achieving that status under a biosimilar prequalification pilot begun by the agency in 2018.   “Rituximab has revolutionized the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukemia and follicular lymphoma, significantly improving therapeutic responses, and remains a fundamental component of treatment regimens...
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    EMA’s CHMP Recommends First Ebola Vaccine, 6 Other Medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus. EMA said that preliminary data suggest the vaccine is effective in the current Ebola outbreak in the De...
  • ReconRecon

    Recon: Novartis Wins FDA Approval for Eye Drug; New ICER Report on Net Drug Price Hikes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis gets FDA boost in crowded eye drug market ( Reuters ) ( PMLive ) ( Press ) ICER Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence ( ICER ) ( Reuters ) ( Stat -$) Continuing Appropriations Act Changes Treatment of Authorized Generics in Medicaid Rebate Average Manufacturer Price ( FDA Law Blog ) FDA leaders worry ...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Planned Changes to Medical Device Rules   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.   Both documents grew out of the Austra...
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    WHO Revises Guidance on QMS Requirements for National Inspectorates

    The World Health Organization (WHO) has revised its guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates to align with international standards and the latest quality management system (QMS) principles and to expand the document’s scope. The guidance outlines what a QMS is, what it should do for an inspectorate and how it should help senior management better achieve their targets and quality objectives. “Senior management’s...
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    WHO Lays Out Five-Year Regulatory Action Plan

    As part of efforts to increase access to quality medical products around the globe, the World Health Organization (WHO) this month crafted a five-year plan to promote regulatory collaboration and reliance, and to help national regulatory authorities (NRAs) solve capacity issues and other challenges. According to WHO surveys, only 30% of NRAs in 2018 had the capacity to effectively and efficiently regulate medical products, although there was greater capacity to regulate...
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    WHO Adopts Weakened Resolution on Drug Price Transparency

    The World Health Organization (WHO) on Tuesday adopted a resolution to urge countries to publicly share the net prices of health products and the costs of clinical trials. The resolution, adopted after three weeks of negotiations, also calls on United Nations member countries to better facilitate the public reporting of patent status information and marketing approval status of health products, as well as to improve national capacities for open and collaborative researc...
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    WHO Details Plan to Combat Antimicrobial Resistance Globally

    The World Health Organization (WHO) finalized a report on combating antimicrobial resistance (AMR), stressing the urgency to act. The final report—developed by the Interagency Coordination Group on Antimicrobial Resistance (IACG)—identifies 14 recommendations centered on the urgency and action needed for a global fight against AMR. “The challenges of antimicrobial resistance are complex and multifaceted, but they are not insurmountable,” WHO said, arguing the report’...
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    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...