• Regulatory NewsRegulatory News

    Health Canada drafts guidance on electronic media in labeling

    Health Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile applications, in prescription drug labeling.   The public consultation runs until 7 May 2021 and seeks feedback from industry, health professionals and the public on the agency’s proposed guidance. The draft guidance is built around Health Canada’s existing legal framework for labeling and explains the agency’s expect...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RF Quarterly

    Modernizing clinical trial regulations in Canada

    This article provides an overview of Health Canada’s plans to modernize its clinical trials regulations and enhance health care agility in the regulatory framework for its health care products by making regulations more flexible and adaptive to innovation. The author discusses how clinical trials in several health care product lines can be modernized and looks at how lessons learned from the COVID-19 pandemic experience can help set up a more flexible regulatory framework ...
  • RF Quarterly

    The Canadian application process and alternate pathway for COVID-19‒related trials

    This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations for Clinical Trials Involving Human Subjects in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range of clinical trial submission requirements and communication with Health Canada’s relevan...
  • Regulatory NewsRegulatory News

    How to handle COVID variants? Global regulators turn to flu vaccines

    A global consortium of regulators is turning to seasonal influenza vaccine authorization as a model for how to address variant-adjusted version of authorized COVID-19 vaccines.   New guidance available from the ACCESS consortium, including the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), directs vaccine developers to focus on demonstrating robust immune response against new variants when trialing modified COVID-19 vaccines. In addition...
  • Regulatory NewsRegulatory News

    EMA, Health Canada publish Moderna data package

    Making good on an earlier commitment to transparency in regulatory decision-making during the COVID-19 pandemic, the European Medicines Agency (EMA), in collaboration with Health Canada, has published the full clinical data package upon which the regulators based their approvals of the COVID-19 vaccine jointly developed by Moderna and the US National Institutes of Health.   The Tuesday announcement of the availability of the data package “highlights the shared commitme...
  • Regulatory NewsRegulatory News

    England and Canada diverge from US on cancer drug decisions

    Regulatory and health technology assessment agencies in Canada and England are diverging from the US when it comes to oncology drugs. But they often rely on the same surrogate endpoints to make their decisions, according to two new analyses published in JAMA Internal Medicine .   The first study , led by Avi Cherla, MSc, of the London School of Economics and Political Science, revealed that among 68 cancer indications with accelerated approval in the US that also rec...
  • Regulatory NewsRegulatory News

    Health Canada greenlights Moderna's COVID vaccine

    Health Canada has authorized a second vaccine against COVID-19, granting Moderna marketing authorization with conditions for the messenger RNA (mRNA) vaccine it co-developed with the US National Institutes of Health.   The authorization for use in individuals aged 18 years and up follows Health Canada’s 9 December authorization of the mRNA COVID-19 vaccine developed by Pfizer and the German firm BioNTech. Both vaccines’ authorizations were issued under an interim or...
  • Regulatory NewsRegulatory News

    Health Canada authorizes Pfizer's mRNA vaccine under interim order

    Health Canada has authorized the use of the COVID-19 vaccine co-developed by Pfizer and the German firm BioNTech for use in individuals 16 years of age and up. The authorization was made under the country’s interim order regarding drug importation, sale and advertising during the COVID-19 pandemic.   The first vaccine doses may be administered within days of the 9 December authorization , depending on transit and delivery logistics required to ship the first doses f...
  • Regulatory NewsRegulatory News

    HHS opens pathway to importing Canadian drugs

    The US Department of Health and Human Services (HHS) has issued a final rule that clears a path for importation of some Canadian drugs into the US. The measure follows a 24 July 2020 executive order issued by President Donald Trump that directed the HHS secretary to take action to expand access to lower-cost imported drugs. In a 24 September press release, the US Food and Drug Administration (FDA) said that the final rule would help affordability of drugs for US patient...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    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...
  • Regulatory NewsRegulatory News

    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...