Health Canada: Special Access Program Regulations Changes
Health Canada’s Special Access Program (SAP), and the Emergency Drug Release (EDR) Program are used when a serious or life-threatening condition may require new drugs when conventional therapies have failed, are unsuitable, or unavailable. The regulations surrounding these programs are currently being renewed to gain faster access to products that are not currently authorized for sale in Canada. The key changes include easier access to previously approved medications, “pre-positioning” medications, shipping to community pharmacies, and a patient’s identity to be unknown at the time of a request.
Please find the attached video which further explains these key changes and their implications.
The full report can be found here.