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  • Regulatory NewsRegulatory News

    Canada’s drug price reforms delayed to 2021

    Amendments to Canada’s Patented Medicines Regulations will now be put in place 1 January 2021, delaying implementation of the sweeping drug pricing reforms by six months.   The new timeline represents a further adjustment from the schedule laid out in 2017, when Health Canada first proposed overhauling its drug pricing review process.   Draft pricing guidelines promulgated by the government of Canada’s Patent Medicine Prices Review Board (PMPRB) have been availab...
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    FDA Explains What Mobile Apps Are No Longer Devices

    A section of the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and removed certain software functions from the definition of a medical device. In addition to drafting new guidance on clinical decision support software, the US Food and Drug Administration (FDA) on Thursday released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations. Examples of such...
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    Health Canada’s Public Release of Drug, Device Clinical Data Picks Up Steam

    Last March, amendments to Canada’s  Food and Drug Regulations and the Medical Devices Regulations enabled the public release of clinical information submitted to Health Canada for new drug and device approvals. But in the first five months after the amendments took effect, just one clinical trial package for a new drug and one clinical trial package for a new device were published. In the last two months, however, Health Canada has published information on eight more d...
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    Regulating Digital Health: Novartis CEO Seeks Further Modernization

    Novartis CEO Vas Narasimhan told attendees of PhRMA’s Innovation Day on Thursday that as biopharmaceutical companies embrace digital technologies to speed the discovery and development of new medicines, regulators will have to adapt more quickly. “FDA has been, more than any other regulator in the world, interested in working with these technologies,” Narasimhan said. But he also opined that when the “rubber hits the road” and companies begin filing applications with th...
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    Canadian Regulator and Regulatory Experts to Speak at 2019 Convergence

    RAPS’ 2019 Regulatory Convergence in Philadelphia will include a session hosted by the Canadian Association of Professionals in Regulatory Affairs (CAPRA). RAPS and CAPRA enjoy a collegial relationship and have collaborated on a number of initiatives in recent years. RAPS is even offering CAPRA members the opportunity to attend this year’s Convergence at the RAPS member rate. This is the second consecutive year CAPRA has hosted a session within RAPS’ signature annua...
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    Digital Health: ‘Connecting the Dots’ Across FDA Centers

    The US Food and Drug Administration’s (FDA) creation of a Digital Health Center of Excellence is in the works, although details offered Wednesday did not shed much light on when it’s coming or its envisioned role.   There are “lots of details to be ironed out,” said Bakul Patel, director for digital health at FDA’s Center for Devices and Radiological Health (CDRH), during a session on Wednesday at the AAMI/BSI/FDA International Conference on Medical Device Standards an...
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    Health Canada Encourages RWE Submissions

    In lock step with its US counterparts, Health Canada this week announced that it’s seeking to better use real-world evidence (RWE), while addressing certain specifics in protocol development and data quality concerns.  As real-world data (RWD) sources increase in quantity and quality, Health Canada explains how “prospectively planned clinical trials have been and continue to be considered the most robust tool for providing evidence of drug safety and efficacy,” although...
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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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    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
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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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    FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD

    The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket assessments of software as a medical device (SaMD) technologies that are powered by artificial intelligence (AI) and machine learning (ML). The agency said it may conduct a “focused review” in cases where proposed SaMD pre-specifications (SPS) and algorithm change protocols (ACP) “can be refined based on the real-...
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    Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software

    The US Food and Drug Administration’s (FDA) regulation of prescription drug-use-related software (PDURS) behooves alignment across relevant centers, industry comments on FDA’s proposed framework argued. From pharmaceutical companies and trade associations to digital health companies and coalitions, the agency’s November 2018 proposed framework for the future regulation of PDURS drew comments from a range of stakeholders. The proposed framework  on PDURS is largely seen...