Canada Noc Guidance
Jkobe Peoples
In 2011, people were provided with numerical limits for weekly and daily amounts of alcohol use. In comparison, the 2023 guidance recommends people consider reducing their alcohol use. To help them make an informed decision about possible alcohol use reduction, the 2023 guidance presents a continuum of risk according to which:
No. The guidance recommends that people consider reducing their alcohol use. The guidance provides people with the information they need to make their own choices about their health. People are going to have different comfort levels with different levels of risk.
CCSA understands that not everyone identifies as female or male. Further research is needed to understand and describe the risks and health effects in a broader gender context. CCSA will continue to bring the public the most up-to-date understanding.
Physiologically, males may require more alcohol than females to experience intoxication and associated harms. However, from a gender perspective, studies show that men are more likely than women to take other risks. When combined with alcohol, men further increase their likelihood of experiencing and causing alcohol-related harms.
Alcohol is a teratogen, a substance that can cause abnormalities or birth defects in a fetus. Alcohol use in pregnancy can lead to learning, health and social effects with lifelong impacts. For this reason, when pregnant or trying to get pregnant, there is no known safe amount of alcohol use.
Alcohol consumption can also negatively impact breastfeeding. It can cause a decrease in milk production, an early end to breastfeeding and effect infant sleep patterns. Within 30 to 60 minutes of drinking, alcohol enters breast milk, so breastfeeding infants can be exposed to alcohol through breastmilk. As infants are less able to metabolize alcohol, when breastfeeding, no alcohol use is safest for the baby.
The evidence no longer supports the idea that alcohol is good for your health. The fact that there is no healthy amount of alcohol use is supported by the World Health Organization and the World Heart Federation.
Any reduction in alcohol use is beneficial. This applies even for those who are unable or unwilling to reduce their risk to low or moderate levels. In fact, those consuming high levels of alcohol have even more to gain by reducing their consumption by as much as they are able.
Health Canada is pleased to announce the release of the finalized Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications which provides guidance to all sponsors [for example (e.g.) industry, academic, contract research organization] seeking authorization to sell or import a drug for the purpose of a clinical trial in Canada. The Guidance was revised based on stakeholder consultation processes and as part of Health Canada's statutory review of Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects).
The Guidance for Clinical Trial Applications (CTAs) is consistent with the new Common Technical Document (CTD) format and is clear on application requirements. This Guidance document supersedes the previous Guidance for Clinical Trial Sponsors: Clinical Trial Applications (June 25, 2003). The revised guidance includes application requirements for comparative bioavailability trials and filing requirements for the importation of clinical trial supplies. It includes clarifications to amendment and notification requirements, study termination and closure criteria, application and review processes, and adverse drug reaction reporting criteria as well as format requirements. All stakeholder comments were considered in the finalization of this guidance document. A table of comments from industry stakeholders in response to the draft CTA Guidance is available upon request.
As a reminder, Health Canada is advising sponsors of the new electronic adverse drug reactions (ADR) reporting that is currently in pilot with some sponsors. Those sponsors who have an established connection with the Canada Vigilance Production stream should submit their reports only to the appropriate Directorates: Therapeutic Products Directorate (TPD), Biologics and Genetic Therapies Directorate (BGTD) or Marketed Health Products Directorate (MHPD) [that is (i.e.) a report no longer needs to be sent in duplicate to multiple directorates]. For the sponsors who have not yet established this connection, they should continue submitting their reports by fax or by courier. The Health Canada website will provide further clarification on Health Canada's ADR reporting requirements.
Improving the quality of CTAs that are submitted by sponsors and gaining efficiencies with CTA screening, regulatory review and safety reporting, will provide benefits to those involved in the conduct of clinical trials, and most of all to Canadians.
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
The Food and Drugs Act and the Food and Drug Regulations (herein referred to as the Regulations) govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides guidance on the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects.
To provide sponsors seeking authorization to conduct a clinical trial in Canada with guidance to support the protection of clinical trial subjects and contributes to the high standards of excellence in research and development in Canada. This document clarifies application and post-authorization requirements and outlines procedures for obtaining authorization.
With the exception of Phase IV studies, clinical trial sponsors must submit a clinical trial application (CTA) to Health Canada for authorization to sell or import a drug for the purpose of a clinical trial.
Clinical trial sponsors must conduct clinical trials according to generally accepted principles of good clinical practice that ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons.
Research Ethics Boards (REBs) have an important role in the oversight of the conduct of clinical trials. Sponsors are required by the Regulations to obtain REB approval for each clinical trial site prior to commencing the trial at that site [C.05.006(1)(c)].
The Regulations are generally consistent with the principles, definitions and standards found in the International Conference on Harmonisation (ICH) Guidance documents on clinical trials. Where inconsistencies exist, the Regulations take precedence.
c80f0f1006