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Drugs and Health Products: Drugs are reviewed to assess their safety, efficacy and quality before being authorized for sale in Canada. Drugs include prescription and nonprescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.
Drug Products   Medical Devices
Applications and Submissions/ Drug Product Database / Search Tips Natural Health Products
Forms Fees Biologics, Radiopharmaceuticals & Genetic Therapies
Guidance Documents Legislation and Guidelines
Policies Notice of compliance
Register of Innovative Drugs Patent Register
Reports Projects
Templates
Health Canada Documents et Guidance pour l'Industrie Pharma & Biotech
Clinical Trials Site Information (CTSI) Form for: Clinical Trial Applications and/or AmendmentsTrial. February 2009
Drug Identification Number (DIN) Submission Certification. May 2009
Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard. February 2009
ADR Expedited Reporting Summary for ADRs Occuring During Clinical Trials. March 2003
Category IV Drug Submission Certification. March 2009
SUBMISSION FEE APPLICATION FORM. November 2004
Post-Notice of Compliance (NOC) Changes Guidance Documents. September 2009
Guidance Document on Post-Drug Identification Number (DIN) Changes. June 2009
Consultation - Draft Guidance Document Non-Clinical Laboratory Study Data Supporting Clinical Trial Applications, New Drug Submissions and Drug Identification Number Applications: Adherence to Good Laboratory Practices. August 2009
Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations. March 2009
Bioavailability and Bioequivalence
Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticas. Mrch 2009
ICH guidance / Efficacy (E1 - E15) and ICH guidance /Safety (S1 - S7)
Quality
Common Technical Document (CTD)
eCTD
Drug Interactions
Good Guidance Practices
Compliance and Enforcement
Enforcement Activities
International Activities
Implementation Plan Between the European Commission (EC), European Medicines Agency (EMEA) and Health Canada. April 2009
Drug Product Database Online Query

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