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Health Canada
Drugs and health products
Drug products
Applications and Submissions - Drug Products
Guidance Documents – Applications and submissions – Drug products
Management of Drug Submissions and Applications
Guidance Document: The Management of Drug Submissions and Applications
[2020-11-26]
Archived Versions
Management of Drug Submissions
[2019-07-25]
Page details
Date modified:
2021-05-26
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Guidance Documents – Applications and submissions – Drug products
Regulatory enrolment process (REP)
Post-Drug Identification Number (DIN) Changes Guidance Document
Guidance Document: Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma - Summary
Notice: Clarification to the Guidance Document: Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act
Drug and Medical Device Databases
Summary: Guidance Document - Plain Language Labelling Regulations for Prescription Drugs
Summary: Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
Summary: Guidance Document - Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits)
Summary: Guidance Document Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs
Guidance on procedures and administrative requirements for master files
Filing submissions electronically
Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs) - Summary
Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs
Consultation of the Draft Guidance Document: Comparative Pharmacokinetic Studies for Orally Inhaled Products
Licensing approach to produce and distribute alcohol-based hand sanitizers: guidance document
Chemical Entity Products/Quality
Common Electronic Submissions Gateway
Disinfectants
Drug Submission Status
Helicobacter pylori
Hormone Replacement Therapy
Inhalers
Non-prescription Drugs: Category IV Monographs
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Official Methods
Oral Contraceptives
Patented Medicines
Priority Review
Product monograph guidance documents and notices
Reconsideration of Final Decisions
The Use of Foreign Reviews
Guidance Document - Human-Use Antiseptic Drugs
Guidance Document Post-Drug Identification Number (DIN) Changes
Guidance Document: Notice of Compliance with Conditions (NOC/c)
Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations
Good Guidance Practices
Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice
Questions and Answers - Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice
Guidance Document: Tamper-resistance Formulations of Opioid Drug Products
Haemodialysis Solutions
Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products
Guidance Document: Labelling of Pharmaceutical Drugs for Human Use
Revised Guidance Document: Acetaminophen Labelling Standard
Drugs Currently Regulated as New Drugs
Listing of Drugs Currently Regulated as New Drugs (The New Drugs List)
ARCHIVED - Notice - Post-Notice of Compliance (NOC) Changes Guidance Documents
Notice Regarding Interim Approach for Evaluating Cardiovascular Risk for New Antidiabetic Therapies to Treat Type 2 Diabetes Mellitus
Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)
Guideline on Preparation of DIN Submissions
Guidance Document: Schedule A and Section 3 to the Food and Drugs Act [Health Canada, 2010]
Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)
Notice: Guidance Document: Post-Drug Identification Number (DIN) Changes
Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs
Notice: Tablet Scoring of Subsequent-entry Pharmaceutical Products
Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product
Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits)
Certificates of Supplementary Protection (CSP) and Applications
Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs
Summary - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales
Notifying Health Canada of Foreign Actions - Guidance Document for Industry
Guidance for health products containing cannabis or use with cannabis
Use of a Foreign-sourced Reference Product as a Canadian Reference
Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document
Harmonizing fludeoxyglucose (F-18 FDG) product monographs
Notice to Stakeholders: Expiration Dating for Medical Gases
Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Overview
Guideline: increasing transparency when presenting safety information in the Development Safety Update Report (DSUR): region-specific requirements for Canada and the United Kingdom
International Council for Harmonisation (ICH)
Organization and document placement for Canadian module 1
Guidance on switching from prescription to non-prescription status: Overview
