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Found 10 records similar to Building a National Strategy for Drugs for Rare Diseases: What We Heard from Canadians

Federal

This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs, including drugs for rare diseases.

Last Updated: Sep. 17, 2020
Date Published: Feb. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Priority review, faster access to drugs, health care system needs.
Federal

The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.

Last Updated: Sep. 17, 2020
Date Published: Jul. 5, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Special Access to Drugs and Health Products, Special Access Programme, access to nonmarketed drugs.
Federal

The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help with product approval and availability.

Last Updated: Sep. 17, 2020
Date Published: Feb. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Improving access to generic drugs, regulatory review of drugs and devices.
Federal

Drugs are authorized for sale in Canada once they have successfully gone through the drug review process, which includes the assessment of the safety, efficacy and quality of the drug. However, Health Canada's SAP allows practitioners to request access to drugs that are not available in Canada for the emergency treatment of patients with serious or life-threatening conditions who have exhausted other treatment options.

Last Updated: Dec. 29, 2021
Date Published: Jul. 21, 2021
Organization: Health Canada
Formats: HTML
Keywords:  notice of clarifications, access to restricted-drugs, Special Access Program, SAP, drug review process, access to drugs, not-available for emergency-treatment, life-threatening conditions, other treatment options
Federal

Health Canada is responsible for helping the people of Canada maintain and improve their health. This is done, in part, by our commitment and actions to help protect the Canadian drug supply, thus ensuring that people in Canada have access to the drugs they need when they need them. Health Canada expects stakeholders across the drug supply chain to make business decisions that keep in mind the stability of the Canadian drug supply.

Last Updated: Dec. 29, 2021
Date Published: Nov. 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Canadian drug supply, drugs distribution guide, GUI-0145, Canadian drug market, drug use-outside Canada, access to drugs, stakeholders across drug-supply-chain, stability of drug-supply
Federal

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.

Last Updated: Jul. 7, 2021
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, post-notice of compliance, NOC Changes, changes to new drugs, safety and efficacy document, pharmaceutical, biologic, radiopharmaceutical, drugs for human use
Federal

A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for marketing considerations. Changes to the labelling of a drug product could include adding new indications, improving the management of risk for a product by adding warnings, limiting the target population or changing the dosage regime etc.

Last Updated: Jul. 7, 2021
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Post-Notice of Compliance, NOC Changes, framework document, pharmaceutical, biologic, radiopharmaceutical drugs, drugs for human use only
Federal

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation associated with rheumatic diseases and other less severe conditions. Each Product Monograph is expected to contain objective, adequate and concise information on properties common to the active component and specific to the drug product. It should provide guidance on the safe and effective use of the drug, not only to the practitioner but also to the patient.

Last Updated: Jul. 7, 2021
Date Published: Aug. 7, 2009
Organization: Health Canada
Formats: HTML
Keywords:  Basic product mMonograph information, non-steroidal anti-inflammatory drugs, NSAIDs, controlling pain and inflammation, rheumatic diseases, product monograph contains objective, adequate and concise information on drug product, safe and effective use of the drug
Federal

The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.

Last Updated: May 5, 2020
Date Published: Jul. 5, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Special Access Program, Non-marketed drugs.
Federal

The NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the Food and Drug Regulations. The database is updated nightly and contains NOC information on human drugs from January 1, 1994 to date. It also contains NOC information on Veterinary drugs from September 19, 2000 to date.

Last Updated: Feb. 24, 2022
Date Published: Dec. 18, 2017
Organization: Health Canada
Formats: XML JSON HTML
Keywords:  NOC, veterinary drugs, DIN
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