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Renewal of the Special Access Programme From Health Canada The Special Access Programme (SAP) is undergoing a renewal to make improvements to its processes. The SAP authorizes access to drugs that are not now authorized for sale in Canada, including drugs for rare diseases. This…

Device advice for medical devices This project will result in new and structured ways for Health Canada to engage and communicate effectively with medical device stakeholders. This will be done through pre-clinical meetings and an e-learning course . We expect a formal meeting…

Building better access to digital health technologies From Health Canada This project will result in: a targeted Health Canada review for digital health technologies greater capacity for digital health technologies, especially emerging innovations such as artificial intelligence…

Improving access to generic drugs This project will: increase review capacity for generic drugs propose amendments to the Food and Drug Regulations to assist the access to generic drugs involve worksharing and information-sharing with other international regulatory partners The…

Improving access to biosimilars and biologics From Health Canada This project will add to the review capacity for biosimilars and biologics by hiring more reviewers. More review capacity through hiring of more reviewers to respond to the increase in drug submissions will result…

Expanding priority review pathways for drugs that meet health care system needs 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…

Worksharing with other international regulatory authorities This project will create a streamlined process for joint reviews between Health Canada and other international regulatory authorities. It will build on our existing relationships with the…

Use of foreign reviews and decisions This project is focussed on achieving 2 distinct goals. These are to: standardize the use of reviews conducted by other Regulatory Agencies (foreign reviews) to gain efficiencies in our review of submissions for prescription drugs for human…

Early scientific advice to manufacturers 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.…

Aligned reviews for certain drugs The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. This project will make sure that the timing of Health Canada and Canadian HTA reviews are better aligned, while facilitating information…