1 / 3

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.

kiral
Download Presentation

Biopharmaceutical Regulatory

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related