Regulatory Decision Summary Health Canada

All drug submissions must undergo rigorous scrutiny and fully satisfy all scientific requirements under the Food and Drug Regulations before any drug can be marketed in Canada. Summary Basis of Decision.

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Health Canada reviewed the RMPs for the AstraZeneca COVID-19 vaccines and found them to be acceptable.

Regulatory decision summary health canada. The document includes regulatory safety effectiveness and quality in terms of chemistry and manufacturing considerations. Français fr Gouvernement du Canada. The RDS includes the purpose of the submission and the reason for the decision.

Report a side effect. Summary Basis of Decision SBD documents provide information related to the original authorization of a product. The documents include regulatory safety effectiveness and quality chemistry and manufacturing considerations.

The RDSs include the purpose of the submission and the reason for the decision. Health Canadas HPFB is the national authority that is responsible for regulating evaluating and monitoring the safety efficacy and quality of drugs biologics genetic therapies and other health products available for the Canadian marketplace. This means more information about medical devices will be available to consumers and more importantly health care providers.

The SBD for is located below. Summary Basis of Decision. Health Care Professionals Researchers.

The Department does this through a combination of scientific review monitoring compliance and enforcement activities. The Regulatory Decision Summary explains Health Canadas decision for the product seeking market authorization. The RDS includes the purpose of the submission and the reason for the decision.

Regulatory Decision Summaries RDSs explain Health Canadas decision for certain health products seeking market authorization. Regulatory Decision Summary for. Health Canada through the Food and Drugs Act regulates the safety efficacy and quality of all pharmaceutical drugs for use by humans in Canada before and after the products enter the Canadian marketplace.

What was the application for at the time of approval. RDSs are posted for positive decisions issued after April 1 2015 for. Report a side effect.

About the Drug and Health Product Register. Summary Basis of Decision. What information did Health Canada review.

The Summary Basis of Decision explains why the product was approved for sale in Canada. Decision issued No decision was issued by Health Canada. Report a serious adverse drug reaction for hospitals Report a medical device problem for health care professionals Prescription Drug List.

Skip to About government Language selection. The Summary Basis of Decision explains why the product was approved for sale in Canada. The Summary Basis of Decision explains why the product was approved for sale in Canada.

Summary Basis of Decision. Skip to main content. The company cancelled its submission before a final decision was issued.

Report a serious adverse drug reaction for hospitals Report a medical device problem for health care professionals Prescription Drug List. This section provides information about all the tools necessary for the industry to comply with the Food and Drugs Act and Regulations. Health Care Professionals Researchers.

About the Drug and Health Product Register. Summary Basis of Decision. The Health Canada website currently includes a medical device.

Health Care Professionals Researchers. The Regulatory Decision Summary explains Health Canadas decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

Find the latest results from the Governments drug and health product inspections. Summary Basis of Decision Summary Basis of Decision SBD documents explain why Health Canada authorized certain drugs and medical devices for sale in Canada. Jobs and the workplace.

In addition to working with the Public Health Agency of Canada and provinces and territories Health Canada also exchanges information with our international regulatory counterparts on an ongoing basis. Health Canada has announced as part of the Regulatory Transparency and Openness initiative online publication of Regulatory Decision Summaries RDS and a list of decisions under review. This collaboration helps to support the review process.

Submit a report. Regulatory Decision Summary - - Health Canada. Submit a report.

Regulatory decision summaries of drugs and health products Understand the decisions to approve or not approve the sale of drugs and medical devices in Canada. Menu Main Menu. These pages also include summaries of certain submissions that were accepted into review and subsequently cancelled by the sponsor.

The reasons for these decisions are in the regulatory decision summaries RDSs.

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