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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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    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
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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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    Danish Medicines Agency Ramps Up Capacity in Medical Devices

    The Danish Medicines Agency's Medical Devices Unit is “massively building up capacity” in the area of medical devices, the agency said Tuesday, to better deal with the incoming EU device legislation and to address rapid changes in technological development. A new fee structure will allow the devices unit to increase its staff capacity from about 14 employees to about 40 employees once all new employees have been recruited next spring. The unit will also work more closel...
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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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    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...