Update: On September 1, 2020, BRDD revised its Report to correct the “Biosimilars: Market Authorizations” tables.
The Therapeutic Products Directorate (TPD), the Biologic and Radiopharmaceutical Drugs Directorate (BRDD; formerly BGTD) and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission Performance Annual Reports for Fiscal Year 2019-2020. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical, and non-prescription and disinfectant drug submission review activity over five consecutive fiscal years (April 1 to March 31) from 2015-2016 to 2019-2020.
Related Publications & Articles
-
Supreme Court of Canada: methods of medical treatment unpatentable, validity of Janssen’s paliperidone dosing regimen patent upheld
Today the Supreme Court of Canada released its decision in Pharmascience Inc v Janssen Inc, 2026 SCC 26 on the patentability of methods of medical treatment, dismissing Pharmascience’s appeal.Read More -
Ministerial Reliance Order permitting Health Canada to rely on decisions of foreign regulators now in force
On July 15, 2026, the Minister of Health’s Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs ("Reliance Order”) was pub...Read More -
Health Canada seeks feedback on pilot to prioritize domestically manufactured generic drug submissions
In a News Release dated July 15, 2026, Health Canada advised that it is modernizing its regulatory processes to improve efficiency while maintaining high standards for safety, efficacy and quality.Read More
