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Open Data Portal Catalogue Dataset
Found 38944 records

Anyone can find out if a submission has been accepted for review by Health Canada by searching the submissions under review list. We publish Regulatory Decision Summaries (RDS). These summaries explain the purpose of the submission and the reason(s) for Health Canada’s decision on certain health products seeking market authorization. You can access RDSs through the Drug and Health Product Register.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Canada’s regulatory approach drugs for rare-diseases find drug reviews-and-decisions

Canada’s health care system is complex and involves the participation of multiple stakeholders, who all have distinct roles in the planning and delivery of healthcare services. Health Canada’s decision-making role in approving a drug for marketing is distinct from the roles of those who make decisions about price-setting and public drug plan reimbursements.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Canada’s regulatory approach drugs for rare-diseases our-role in-bringing drugs-to-patients

The file contains record for every offender serving a sentence of two years or more under Correctional Services of Canada (CSC) jurisdiction. The data were extracted from the Offender Management System (OMS) and reflects the status and attributes of offenders as of the year end. This file contains links to all of the offender profiles since 2012 and will get updated annually.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Correctional Service of Canada
Formats: HTML
Keywords: Offenders profile data jurisdiction

Special access programs.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: clinical trials special access programs

To develop options for the registration and disclosure of clinical trial information of health products in Canada, Health Canada began consulting with Canadians in 2005.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: clinical trials registration disclosure of information clinical trial information health products

Drug and medical device approval overview

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug medical device approval overview

The purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window approach and more efficient submission processing system, while ensuring that combination products marketed in Canada are safe, effective, and of high quality.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug medical device drug/medical-device combination combination products timely access single window approach efficient-submission processing system combination products marketed

Briefing Package for the hearing before the Standing Committee on Public Accounts on 2023 Report 2, Connectivity in Rural and Remote Areas of the Office of the Auditor General of Canada

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Office of the Auditor General of Canada
Formats: HTML
Keywords: OAG PACP 2023 Report 2 Connectivity in Rural and Remote Areas

This guidance is intended to assist sponsors in the collection and analysis of data for Steroid Nasal products for use in the treatment of allergic rhinitis, in order to meet the safety and effectiveness requirements under Part C, Division 8 of the Food and Drug Regulations.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: final guidance document data requirements safety and effectiveness steroid nasal products allergic rhinitis

Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the F&DA either as a pharmaceutical drug subject to the Food and Drug Regulations and requires a Drug Identification Number (DIN), or as a natural health product subject to the Natural Health Products Regulations and require a Natural Product Number (NPN).

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: classification dental-plaque-disclosing products products as drugs pharmaceutical drug Drug Identification Number natural health product Natural Product Number