Health Canada – Publication of 2 Reports
On July 3, 2020, Health Canada released an update on the key drugs and medical devices approved by Health Canada between January and June 2020. The focus is on the support of the fight against COVID-19. This pandemic has created an unprecedented demand on Canada’s health care system. Health Canada has played a key role in Canada’s response to COVID-19 by working with partners and stakeholders to ensure essential health products and medical supplies are available for Canadians. Canada is strongly part of the ACSS Consortium (see below).
Canada continues to authorize many other drugs and medical devices which are vital to the health of Canadians.
Health Canada also published the ‘5th annual Drug and Medical Devices Highlights Report’ on the accomplishments of 2019. This document is well described in its title.
Public Disclosure of Clinical Trial Results
Regulatory agencies worldwide are calling for transparency for protocols and results as well as collaboration between researchers to ensure high quality powerful studies. To facilitate this there are numerous dedicated COVID-19 response groups which encourage researchers to register their pharmacoepidemiologic studies and make study protocols and reports public to ensure transparency on the various research efforts. The need has propelled the established World Health Organization’s sponsored International Clinical Trials Registry Platform (ICTRP) into the spotlight. The ICTRP published an internationally endorsed new standard which outlines content and which has spawned secondary projects on :
- clinical trials registration requirements
- public disclosure of results
- reporting timeframes
- a universal trial number UTN
- trial ID in clinical trial publication,
- registration and reporting of past trials,
- notes on sharing of individual participants’ data,
- notes on open access policies
- a note on the scope of the statement.
While this statement and standard focuses on clinical trials, the transparency and reduction of waste and reporting bias are important for other types of research including public health intervention studies, observational studies, implementation research and pre-clinical studies of experimental therapeutics and preventives. The WHO and ICTRP encourages formative work on development of possible transparency frameworks for these types of research, including how best to develop registries that publicly disclose research studies in the above categories.
Most of the regulatory authorities have now announced that they are preparing for the resumption of priority domestic inspections of regulated facilities and associated activities including clinical trials. Several are resuming activities this summer including the FDA (US) and the EMA (EU). These will be done either virtually (remote inspections) or in a hybrid fashion (a virtual on-site combination) depending upon the regulatory agency. Most inspections will be determined with a new risk assessment system that was previously proposed by PICs using a common rating system to determine when and where it is safe to conduct priority domestic inspections. The regulatory agencies are individually working on plans for optimizing operations and new work arrangements along with instructions for sites, institutions, sponsors and contracted agencies. Inspections will be pre-announced with the health and safety of investigators and the public in mind.
ICMRA Outlines Phase 3 COVID-19 Vaccine Trials Criteria
A new report issued this month has had significant impact on what will be the requirements for the developers of candidate vaccines for novel coronavirus SARS-COV-2, the virus that causes COVID-19. The report was issued by the International Coalition of Medicines Regulatory Authorities and Councils following a first meeting on June 22, 2020. Twenty-eight countries, 20 regulatory authorities and lead international regulatory experts in policy and governance, worked together on the report which harmonizes the development of the vaccines. There was agreement on details related to process, when a vaccine should proceed to Phase 3 clinical trials and what the trials designs should look like. The report outlines policy on ‘stringent success criteria’ that allows for convincing demonstration of the efficacy of COVID-19. Canada was represented at the meeting by health authority and council. Authorities in attendance and most others have committed to the recommendations of the report. The international regulatory environment has embarked on a new level of cooperation, which is likely to continue. The accomplishment of this policy in a single day is most notable and unprecedented.
The ACSS Consortium is a medium-sized coalition, which was formed in 2007 by ‘like-minded’ regulatory authorities to promote greater regulatory collaboration and alignment of regulatory requirements. The ACSS member composition is Australia, Canada, Switzerland and Singapore. Canada is working within this group to maximize international cooperation, reduce duplication, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products. The consortium also leverages resources and expertise.
ACSS regulators have published a statement pledging support to tackle COVID-19.
To address this worldwide public health crisis, ACSS members are collaborating to advance the regulatory science needed to support the rapid development of diagnostic tests, as well as vaccines and treatments against COVID-19. Consortium members remain committed to review and collaborate on possible COVID-19 investigational vaccines and treatment options, with the goal of expediting their development.