Annual Drug Submission Performance Reports released. The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) have released their Drug Submission Performance Annual Reports. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity over five consecutive fiscal years (April 1 to March 31) from 2011-12 to 2015-16.

Therapeutic Products Directorate Report

Biologics and Genetic Therapies Directorate Report

Final Guidance Document: Notice of Compliance with conditions (NOC/c) released. On September 16, 2016, Health Canada released the final version of the Guidance Document: Notice of Compliance with conditions (NOC/c). The Guidance Document replaces the “Dear Healthcare Professional Letter” with the “Notice of Market Authorization with Conditions”, which will be completed by Health Canada and appear in Health Canada’s monthly publication Health Product InfoWatch.

Notice

Guidance Document: Notice of Compliance with conditions (NOC/c)