Lengthy process to approve medicines and medical devices in Canada
in CanadaTrade barrier summary
Canada's approval process for medicines and medical devices, including pharmaceuticals, generally takes longer than other countries. This affects UK exporters as it delays reimbursement of their investment. It also reduces their patent exclusivity period in Canada. The Canadian assessment period is 300 days, with 10 days for eCTD validation, following by 45 days for administrative screening, so the procedure will typically extend to 355 days. The FDA in the United States aim to complete the same approval process within 10 months. The health technology assessment process in Canada had extra layers added 12 years ago. This process occurs after the approval of the medicine or medical device and involves assessments on the value of the product. This requires a comparison to products already on the market, assigning it a cost and negotiating what buyers are willing to pay.
Sectors affected
- Pharmaceuticals and biotechnology
- Medical devices and equipment
Resolved
No
Date reported
19 January 2021
Last updated
1 June 2022
Public ID
PID-9LJY6B
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