Open Government Portal
Found 10 records similar to Improving the regulatory review of drugs and devices: Drugs - Special Access to Drugs and Health Products
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.
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.
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.
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.
This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to give scientific advice to manufacturers at the same time early in the drug development process.
The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make sure that the timing of Health Canada and Canadian HTA reviews are better aligned.
Immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. Therefore, the Minister of Health, pursuant to subsection 30.1(1)Footnote1 of the Food and Drugs ActFootnote2, makes this Interim Order: Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.
The Drug Facts Table for Non-prescription Drugs Guidance Document gives direction for designing safe and clear labels and packages.
The Access to Drugs in Exceptional Circumstances regulatory pathway enables access to drugs which have been authorized for sale in certain foreign jurisdictions, but are not available in Canada, to address urgent public health needs. This pathway is intended for public health events that are exceptional in nature and that are occurring (or imminent) and require immediate action.
Interim Order No. 2 Respecting Drugs, Medical Devices, and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2) was signed on March 1, 2021.