• FDA launches digital health center of excellence

    A new digital health Center of Excellence within the US Food and Drug Administration (FDA) aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.   The DHCoE’s website details services offered, including examples of CDRH-specific, FDA-wide and external efforts to “translate digital advances into tools that benefit consumers.” The Center is housed within FDA’s Center for Devices and Radiological Health (...
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    RAPS welcomes new Ontario Chapter

    RAPS has announced the official launch of the RAPS Ontario Chapter , which first began as a RAPS-affiliated local networking group. Ontario joins Vancouver as the second RAPS chapter in Canada and expands RAPS’ global network to now include 20 chapters and eight local networking groups. “We are very excited about the formal launch of our chapter in the RAPS regulatory community,” said founding member and Ontario chapter chair, Ntsakisi Onibayo, RAC, regulatory complian...
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    Medical cannabis regulation is a global patchwork

    (Editor's note: this article was updated to clarify which products made from cannabis or hemp plants fall under Health Canada's Natural Health Products category.) The framework for regulating cannabis as a pharmaceutical product varies widely across the world, though increased clinical research into cannabis products means more approvals are likely under any scenario.   “It’s currently a complex patchwork of approaches,” Michael Craig, a principal consultant at Pa...
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    Regulatory Focus, August issue: Global clinical trials, clinical trial applications

    Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics sup...
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    ICH updates: E14 consultation, Health Canada implements M9 guideline

    The International Council for Harmonisation (ICH) on Thursday announced its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.   On Friday, the European Medicines Agency (EMA) opened a three-month public consultation to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the docum...
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    Health Canada adopts ICH pediatric drug development guidance

    Health Canada is implementing a guidance for nonclinical safety testing to support pediatric medication development.   The guidance was developed by the International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH), and carries the title Guidance S11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines . The Canadian guidance is being fully implemented without modifications, a commitment Health Canad...
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    Canada extends non-COVID clinical trial review times

    Health Canada will have an additional 15 days to review clinical trial applications for drugs that are unrelated to the coronavirus disease (COVID-19) pandemic through 16 November, after Canada’s Minister of Health Patricia Hajdu ordered the extension last week.   Normally, Health Canada has 30 days to review clinical trial applications and amendments for drugs submitted under Division 5 of the country’s Food and Drug Regulations . If the agency does not object to a...
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    Regulators discuss accelerated approvals, Project Orbis at DIA

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada gave their perspectives on different issues related to accelerated approval pathways in their respective jurisdictions at the DIA Global Annual Meeting.   All three regulators offer their own form of accelerated approval based on less comprehensive clinical data than a traditional marketing approval would require. In the US, that pathway is dubbed accelerated ap...
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    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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    Health Canada releases guidance to streamline COVID-19 clinical trials

    Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.   The IO has dropped administrative requirements for non-significant changes during a...
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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...