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- Drug regulators in Canada and in other nations require innovative pharmaceutical companies to submit undisclosed clinical or other data as a condition of approving the marketing of new pharmaceutical products—the origination of which involves considerable effort and investment.
liebertpub.com/doi/full/10.1089/blr.2016.29030.mkA Decade of Data Protection for Innovative Drugs in Canada ...
Jun 22, 2017 · Ten of Canada's largest drug companies voluntarily released information about how much money they give physicians, posting the disclosures to their websites Tuesday. The participating...
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- Purpose
- Scope and Application
- Policy Objectives
- Policy Statements
- Background
- Note on Guidance Documents in General
Health Canada is the federal regulator responsible for the regulation of clinical trials involving a wide range of products, including: 1. drugs that are: 1.1. biologic 1.2. pharmaceutical 1.3. radiopharmaceutical 2. medical devices 3. natural health products (NHPs) Clinical trials are an important step in health product development. They are essen...
Currently, Health Canada authorizes the sale and importation of drugs, medical devices and NHPs for the purpose of conducting clinical trials or investigational testing involving human participants. In addition, Health Canada introduced regulations authorizing the: 1. sale and importation of COVID-19 drugs and medical devices for the purposes of a ...
To provide guidance to sponsors of Health Canada-authorized clinical trials to support the registration and public disclosure of results (reporting of results) using international registries. Additionally, this document describes the clinical trial information that Health Canada is publishing on the Health Canada Clinical Trials Portal.
This policy aims to improve public access to information about clinical trials in Canada by addressing elements relating to: 1. registration 2. reporting of results 3. access Canadian sponsors should register their Health Canada-authorized clinical trials before recruitment of the first participant. This should be done in accordance with requiremen...
Health Canada is advancing the modernization of its clinical trial regulations to better serve stakeholders, while continuing to protect the safety of clinical trial participants. Health Canada conducted consultations on the proposed clinical trials modernization initiative. The feedback we received supports mandatory registration and reporting of ...
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Heath Canada staff on how mandates and objectives should be met fairly, consistently and effectively. Guidance documents are administrative, not legal, instruments. This means that f...
Mar 6, 2024 · Canada’s disclosure guidelines don’t require pharma companies to disclose which doctors and organizations have received payments, or what they have done to earn the money. (Shutterstock)
Mar 20, 2019 · Eligible persons may request unredacted CBI, subject to eligibility requirements, from Health Canada under paragraph 21.1(3)(c) of the FDA, or directly from the manufacturers’ clinical information disclosure portals.
Aug 11, 2017 · A group of Canadian healthcare leaders wants pharmaceutical companies to have to disclose how and why they pay people who prescribe their drugs, saying it would show potential bias and help...
Jun 28, 2018 · In the meantime, the ground has shifted: Last fall, Ontario passed the first legislation in Canada requiring the makers of drugs and medical devices to divulge their payments to a wide array of...
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Does Canada require pharma companies to disclose medical information?
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Sep 27, 2017 · Under new legislation tabled Wednesday, Ontario would become the first Canadian province to require public disclosure of pharmaceutical companies’ payments to doctors and other health-care...
