Open Government Portal

Found 10 records similar to Improving the regulatory review of drugs and devices: Improving access to generic drugs

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

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

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.

Last Updated: Sep. 17, 2020
Date Published: Feb. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Early scientific advice, Health Canada and Health Technology Assessment.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Jun. 22, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Aligned reviews, Health Canada and Health Technology Assessment.
Federal

The Drug Facts Table for Non-prescription Drugs Guidance Document gives direction for designing safe and clear labels and packages.

Last Updated: Sep. 9, 2021
Date Published: Aug. 21, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, Non-prescription drugs, a new Drug Facts Table, supporting improved labelling
Federal

Understand the decisions to approve or not approve the sale of drugs and medical devices in Canada.

Last Updated: Sep. 17, 2020
Date Published: Oct. 23, 2016
Organization: Health Canada
Formats: HTML
Keywords:  Regulatory decision, drug and health product review and approval, sale of drugs and medical devices.
Federal

Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

Last Updated: Jul. 8, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Notice, submission filing recommendations, veterinary drugs, good manufacturing practices, drug establishment licences
Federal

When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada

Last Updated: Jul. 6, 2021
Date Published:
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, regulatory requirements, DIN, drug identification numbers, summary, a drug to be marketed in Canada, DIN printed on the package labels, prescription and non-prescription drugs, obtain a DIN
Federal

This regulatory roadmap gives comprehensive, general information about the regulation of radiopharmaceutical drugs for human use in Canada.

Last Updated: Jun. 7, 2022
Date Published: Mar. 3, 2022
Organization: Health Canada
Formats: HTML
Keywords:  regulatory roadmap, radiopharmaceutical, drugs in Canada, regulation of radiopharmaceutical-drugs
Federal

The Canadian market now includes a much larger number of drugs that reflect a wider range of risks. Our drug regulatory system needs to be more agile to give people better access to the drugs they need.

Last Updated: Jun. 7, 2022
Date Published: Feb. 24, 2022
Organization: Health Canada
Formats: HTML
Keywords:  regulatory-innovation for health-products, advanced therapeutic products, agile-licensing for drugs, clinical-trials, regulatory innovation, modernizing clinical-trial regulations
Date modified: