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...

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...

This article explores the Office of Prescription Drug Promotion’s (OPDP’s) views on public health emergencies, including COVID-19, and how this affects drug promotion. The author reviews trends in past enforcement letters and concludes that promotional materials relating to current public health emergencies are heavily scrutinized by OPDP, which regulatory advertising and promotion reviewers should bear in mind.   Introduction The COVID-19 pandemic has caused innumer...

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...

This article discusses the critical need for clear, precise, and consistent communication on the part of regulatory professionals in interactions and submissions with health authorities. It presents various approaches and offers examples for the regulatory professional to draw on to improve the clarity of such communications.   Introduction As a regulatory professional, one is constantly reaching for and achieving new goals. Whether it is initiation of a first-in-hum...

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 (...

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...

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...

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...

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...

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...

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...