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Departments and agencies
Health Canada
Drugs and health products
Drug products
Applications and Submissions - Drug Products
Guidance documents on applications and submissions for drug products
Oral Contraceptives
Guidance for Industry: Clinical Development of Steroidal Contraceptives Used by Women
[2002-10-29]
Guidelines for the Toxicological Evaluation of Contraceptive Steroids
[2000-04-19]
Page details
2017-05-04
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Guidance documents on applications and submissions for drug products
Overview: Draft guidance on the plain language labelling regulations for prescription drugs
Guidance on notifying Health Canada of foreign actions
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Consultation of the Draft Guidance Document: Comparative Pharmacokinetic Studies for Orally Inhaled Products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
Clinical Development of Steroidal Contraceptives Used by Women
Guidelines for the Toxicological Evaluation of Contraceptive Steroids
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
Overview: Guidance on management of drug submissions and applications
Labelling of pharmaceutical drugs for human use: Guidance document
Overview: Guidance on the Food and Drug Regulations for public health emergency drugs
Overview: Guide to the environmental risk management authorities under the Food and Drugs Act
Overview: Guide to the precision regulating authorities under the Food and Drugs Act
