Biopharmaceutical Regulatory Requirements 40

Marketing Authorization for New Chemical Entities Health Canada’s (HC) Therapeutic Products Directorate (TPD) responsible for drug testing and approval New drug submissions required to undergo safety, efficacy and quality testing by TPD Average approval time: 18 months from submission of New Drug Submission (NDS) until the TPD makes a marketing decision Priority review (target of 180 days) available for certain drugs (“extraordinary use new drug submission”) HC is an official observer and active participant in International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ICH guidelines and standards adopted by HC 41

Marketing Authorization for Biologics and Biosimilars Biological drugs undergo the same procedure and testing requirements as new chemical entities Subsequent entry biologics (biosimilars) pathway introduced in 2010 Canadian biosimilar pathway resembles that used by the European Medicines Agency (EMA) Key difference: Applicants may use biological reference products that have not received market approval in Canada RDP protection/periods the same for biologics and biosimilars as for small molecule drugs 42