Biopharmaceutical RegulatoryRequirements

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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 andquality testing by TPD

• Average approval time: 18 months from submission of New DrugSubmission (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 InternationalConference on Harmonisation of Technical Requirements forRegistration of Pharmaceuticals for Human Use (ICH)

• ICH guidelines and standards adopted by HC

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Marketing Authorization for Biologics and Biosimilars

• Biological drugs undergo the same procedure and testingrequirements as new chemical entities

• Subsequent entry biologics (biosimilars) pathway introduced in2010

• Canadian biosimilar pathway resembles that used by theEuropean Medicines Agency (EMA)

• Key difference: Applicants may use biological reference productsthat have not received market approval in Canada

• RDP protection/periods the same for biologics and biosimilars asfor small molecule drugs

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