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
-
Agile licensing amendments registered
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered.Read More -
2024 highlights in Canadian life sciences IP and regulatory law
In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law.Read More -
Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article re...Read More