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Biopharmaceutical Regulatory

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.

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Biopharmaceutical Regulatory

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  1. BiopharmaceuticalRegulatory Requirements 40

  2. MarketingAuthorizationforNewChemicalEntities •HealthCanada’s(HC)TherapeuticProductsDirectorate(TPD) responsiblefordrugtestingandapproval •Newdrugsubmissionsrequiredtoundergosafety,efficacyand qualitytestingbyTPD •Averageapprovaltime:18monthsfromsubmissionofNewDrug Submission(NDS)untiltheTPDmakesamarketingdecision •Priorityreview(targetof180days)availableforcertaindrugs (“extraordinaryusenewdrugsubmission”) •HCisanofficialobserverandactiveparticipantinInternational ConferenceonHarmonisationofTechnicalRequirementsfor RegistrationofPharmaceuticalsforHumanUse(ICH) •ICHguidelinesandstandardsadoptedbyHC 41

  3. MarketingAuthorizationforBiologicsandBiosimilars •Biologicaldrugsundergothesameprocedureandtesting requirementsasnewchemicalentities •Subsequententrybiologics(biosimilars)pathwayintroducedin 2010 •Canadianbiosimilarpathwayresemblesthatusedbythe EuropeanMedicinesAgency(EMA) •Keydifference:Applicantsmayusebiologicalreferenceproducts thathave notreceivedmarketapprovalinCanada •RDPprotection/periodsthesameforbiologicsandbiosimilarsas forsmallmoleculedrugs 42

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