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Guidance documents for drug products

Guidance documents interpret policies, governing statutes and regulations. Refer to the appropriate guidance document or other resources to help you with an application or submission.

Guidance documents and supporting resources
Subject Title Type Acts and regulations
Reliance Draft guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities Guidance Food and Drugs Act, Food and Drugs Regulations
New authorities ARCHIVED - Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities - What We Heard Report Food and Drug Regulations
Labelling Archived - Labelling standard: Ethylene oxide gaseous products used in sterilization processes Standard Food and Drug Regulations
Notice of compliance ARCHIVED - Notice - Post-Notice of Compliance (NOC) Changes Guidance Documents Notice Food and Drug Regulations
Labelling ARCHIVED - Notice: Release of Revised Draft Guidance Document: Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names Notice Food and Drug Regulations
Disinfectants ARCHIVED Guidance document - Disinfectant drugs Guidance Food and Drug Regulations
Disinfectants ARCHIVED Guidance document - Management of Disinfectant Drug Applications (effective April 1, 2020) Guidance Food and Drug Regulations
Disinfectants ARCHIVED Guidance document - Management of Disinfectant Drug Applications (January 2018) Guidance Food and Drug Regulations
Disinfectants ARCHIVED Guidance document - Safety and Effectiveness Requirements for Contact Lens Disinfectants (2018) Guidance Medical Devices Regulations
Disinfectants ARCHIVED Guidance document - Safety and efficacy requirements for hard surface disinfectant drugs Guidance Food and Drug Regulations
Clinical trials ARCHIVED Guidance on applications for drug clinical trials under the interim order Guidance Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
New authorities ARCHIVED: Amendments to the Food and Drugs Act: Guide to New Authorities (power to require and disclose information, power to order a label change and power to order a recall Guide Medical Devices Regulations
Labelling Basic Product Monograph Information for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Monograph Food and Drug Regulations
Applications and submissions Certificate of Supplementary Protection Regulations (CSP) List Food and Drugs Act
Quality Chemical Entity Products/Quality Guidance Food and Drugs Act
Labelling Closed consultation: Draft guidance on the plain language labelling regulations for prescription drugs Consultation Food and Drug Regulations
Applications and submissions Common Electronic Submissions Gateway (CESG) Guidance Food and Drugs Act
Inhalers Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document Guidance Food and Drug Regulations
Regulatory Confidential Business Information - Disclosure under Paragraph 21.1(3)(c) of the Food and Drugs Act General Food and Drugs Act
Clinical trials Consultation: Draft guidance on decentralized clinical trials Consultation Food and Drugs Act
Terms and conditions Consultation: Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions Consultation Agile regulations
Terms and conditions Consultation: Draft guidance on terms and conditions for human and veterinary drugs Consultation Agile regulations
Clinical trials Consultation: Modernizing the framework for clinical trials Consultation Clinical trials modernization
Disinfectants Contact lens disinfectants monograph Monograph Food and Drug Regulations
Clinical trials Draft guidance document for clinical trial sponsors: SGBA plus demographics action plan in clinical trial applications Guidance - consultation Clinical trials modernization
Foreign reviews Draft Guidance Document: The Use of Foreign Reviews by Health Canada and revisions to the Use of Foreign Reviews pilot project Guidance - consultation Food and Drug Regulations, Medical Devices Regulations
Bioavailability and bioequivalence Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format Guidance - consultation Food and Drug Regulations
Clinical trials Draft guidance on clinical trial applications for clinical trial sponsors Guidance - consultation Clinical trials modernization
Clinical trials Draft guidance on expanded access clinical trials: Closed consultation Consultation Food and Drug Regulations
Terms and conditions Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions Guidance - consultation Agile regulations
Clinical trials Draft guidance on proposed new Clinical Trials Regulations (GUI-0100) Guidance - consultation Clinical trials modernization
Terms and conditions Draft guidance on terms and conditions for human and veterinary drugs Guidance - consultation Agile regulations
Labelling Draft guidance on the plain language labelling regulations for prescription drugs Guidance - consultation Food and Drug Regulations
Data Drug and medical device databases List Patented Medicines (Notice of Compliance) Regulations
Applications and submissions Drug Submission Status List n/a
Regulatory Drugs Currently Regulated as New Drugs List n/a
Applications and submissions Fees for human drugs Guidance Food and Drugs Act
Applications and submissions Filing Submissions Electronically Guidance Food and Drugs Act
Bioavailability and bioequivalence Final Guidance Document Data Requirements for Safety and Effectiveness of Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis for Industry Guidance Food and Drug Regulations
Regulatory Food and Drug Administration Links List n/a
Foreign reviews Foreign Review Attestation Template n/a
Foreign reviews Foreign Review Attestation and Summary of Quality Differences: Subsequent Market Entry Products (Human Drugs) Template n/a
Foreign reviews Frequently Asked Questions (FAQs) - The Use of Foreign Reviews by Health Canada FAQ Access to Information Act
Regulatory Frequently Asked Questions - Common Electronic Submissions Gateway FAQ n/a
Labelling Frequently Asked Questions - Guidance Document for Industry - Review of Drug Brand Names FAQ Food and Drug Regulations
Labelling Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products Guide Food and Drug Regulations
Labelling Good Label and Package Practices Guide for Prescription Drugs Guide Food and Drug Regulations
Good manufacturing practices Good manufacturing practices General Food and Drug Regulations
Good manufacturing practices Good manufacturing practices guide for drug products (GUI-0001) - Summary Guidance - summary Food and Drugs Act
Pharmacovigilance Good pharmacovigilance practices guidelines (GUI-0102) Guidelines Food and Drug Regulations
Pharmacovigilance Good pharmacovigilance practices inspection approach policy for human drugs (POL-0041) Policy Food and Drug Regulations
Bioavailability and bioequivalence Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects Guidance Food and Drug Regulations
Antiseptics Guidance Document - Human-Use Antiseptic Drugs Guidance Food and Drug Regulations, Natural Health Products Regulations
Clinical trials Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals Guidance Food and Drug Regulations
Disinfectants Guidance document - Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices (2018) Guidance Medical Devices Regulations
Clinical trials Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications Guidance Food and Drug Regulations
Labelling Guidance Document for Industry - Review of Drug Brand Names Guidance Food and Drug Regulations
Adverse reactions Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs Guidance Safety of Human Cells, Tissues and Organs for Transplantation Regulation
Applications and submissions Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice Guidance Food and Drug Regulations
Biologics Guidance document on submission information for biologic drugs (Division 4, Schedule D) Guidance Agile regulations
Regulatory Guidance Document on the Distribution of Drugs as Samples - Summary Guidance - summary Food and Drugs Act
DIN (Drug identification number) Guidance Document Post-Drug Identification Number (DIN) Changes Guidance Food and Drug Regulations
Bioavailability and bioequivalence Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies Guidance Food and Drug Regulations
Clinical trials Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences Guidance Food and Drug Regulations, Natural Health Products Regulations
Data Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations Guidance Food and Drug Regulations
Applications and submissions Guidance Document: Determining Prescription Status for Human and Veterinary Drugs Guidance Food and Drugs Act
Labelling Guidance Document: Drug Facts Table for Non-prescription Drugs Guidance Food and Drugs Act
DIN (Drug identification number) Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) (effective April 1, 2020) Guidance Food and Drug Regulations
DIN (Drug identification number) Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) (effective December 13, 2017) Guidance Food and Drug Regulations
Applications and submissions Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience) Guidance Food and Drug Regulations
Labelling Guidance document: Labelling of pharmaceutical drugs for human use Guidance Food and Drugs Act, Controlled Drugs and Substances Act
Notice of compliance Guidance document: Notice of Compliance with Conditions (NOC/c) Guidance Food and Drug Regulations
Notice of compliance Guidance Document: Patented Medicines (Notice of Compliance) Regulations Guidance Patented Medicines (Notice of Compliance) Regulations
Hepatoxicity Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products Guidance Food and Drug Regulations, Natural Health Products Regulations
Clinical trials Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans Guidance Food and Drug Regulations
Labelling Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (revised 2018) Guidance Food and Drug Regulations
Labelling Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (revised 2020) Guidance Food and Drug Regulations
Applications and submissions Guidance document: Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions Guidance Food and Drug Regulations, Natural Health Products Regulations
DIN (Drug identification number) Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs) - Summary Guidance - summary Food and Drug Regulations, Biocides Regulations
Labelling Guidance Document: Schedule A and Section 3 to the Food and Drugs Act [Health Canada, 2010] Guidance Food and Drug Regulations, Natural Health Products Regulations
Opioids Guidance Document: Tamper-resistance Formulations of Opioid Drug Products Guidance Food and Drug Regulations
Applications and submissions Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product Guidance Food and Drug Regulations
Good manufacturing practices Guidance Documents – Good Manufacturing Practices List n/a
Veterinary drugs Guidance Documents – Legislation and guidelines – Veterinary drugs List Food and Drug Regulations
Applications and submissions Guidance for Industry - Priority Review of Drug Submissions Guidance Food and Drug Regulations
Post-market Guidance for industry on safety monitoring and reporting requirements for marketed biocides Guidance Biocides Regulations
Clinical trials Guidance for Industry: Standards for Clinical Trials in Type 2 Diabetes in Canada Guidance Food and Drug Regulations
Regulatory Guidance for health products containing cannabis or for use with cannabis Guidance Food and Drugs Act
COVID-19 Guidance on applications for COVID-19 drug clinical trials under the Regulations Guidance Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
Clinical trials Guidance on expanded access clinical trials Guidance Food and Drug Regulations
Applications and submissions Guidance on information and submission requirements for biosimilar biologic drugs Guidance Food and Drug Regulations
Applications and submissions Guidance on management of drug submissions and applications Guidance Food and Drug Regulations
Confidential business information Guidance on procedures and administrative requirements for master files Guidance Natural Health Products Regulations
Applications and submissions Guidance on switching from prescription to non-prescription status Guidance Food and Drug Regulations, Natural Health Products Regulations
Terms and conditions Guidance on terms and conditions for class II to IV medical devices Guidance Medical Devices Regulations
Applications and submissions Guidance on the Food and Drug Regulations for public health emergency drugs Guidance Food and Drug Regulations
Biologics Guidance on the Lot Release Program for Schedule D (biologic) drugs Guidance Agile regulations
Inhalers Guidance to Establish Equivalence or Relative Potency of Safety and Efficacy of a Second Entry Short-Acting Beta2-Agonist Metered Dose Inhaler (MDI) [Health Canada, 1999] Guidance Food and Drugs Act
New authorities Guide to the environmental risk management authorities under the Food and Drugs Act Guide Food and Drug Regulations
New authorities Guide to the precision regulating authorities under the Food and Drugs Act Guide Food and Drugs Act
DIN (Drug identification number) Guideline on Preparation of DIN Submissions Guidelines Food and Drug Regulations
Labelling Haemodialysis Solutions Monograph Food and Drug Regulations
Disinfectants Hard Surface Disinfectants Monograph - Revised Monograph Food and Drug Regulations
Applications and submissions Health Canada updates guidance on management of drug submissions and applications: Notice Notice Food and Drug Regulations
Clinical trials Helicobacter pylori List n/a
Regulatory How to use the Common Electronic Submissions Gateway to send regulatory transactions to Health Canada General n/a
Inhalers Inhalers List n/a
Clinical trials Instructions for completing the Clinical Trial Site Information Form Notice Food and Drug Regulations
International Council for Harmonisation International Council for Harmonisation (ICH) General n/a
Labelling Labelling requirements for non-prescription drugs guidance document Guidance Food and Drug Regulations
Applications and submissions Listing of Drugs Currently Regulated as New Drugs (The New Drugs List) Notice Food and Drug Regulations
Adverse reactions Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals: Overview Guidance Food and Drug Regulations, Medical Devices Regulations
Applications and submissions New agile regulatory provisions and updated guidance document for submitting risk management plans: Notice Notice Agile regulations
Applications and submissions New draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy: Notice Notice Agile regulations
Labelling Non-prescription Drugs: Category IV Monographs List Food and Drug Regulations, Natural Health Products Regulations
Labelling Non-prescription Drugs: Labelling Standards - Drug Product List Natural Health Products Regulations
Post-market Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) List n/a
Applications and submissions Notice - Revision to Guidance Document: Submission of Pharmacogenomic Information Guidance Food and Drug Regulations
Clinical trials Notice to stakeholders – Clarification of requirements under the Food and Drug Regulations when conducting clinical trials with cannabis Notice Food and Drug Regulations
Clinical trials Notice to Stakeholders: Statement on the Investigational Use of Marketed Drugs in Clinical Trials Notice Food and Drug Regulations
International Council for Harmonisation Notice – Implementation of International Council for Harmonisation (ICH) S1B(R1): Testing for Carcinogenicity of Pharmaceuticals Notice n/a
Applications and submissions Notice, Guidance for Industry Drug Submission Status Requests: Therapeutic Products Directorate Notice n/a
Inhalers Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma Notice Food and Drug Regulations
Regulatory Notice: Guidance document updates to reflect new fees and policies for April 1, 2020 Notice Food and Drugs Act
Applications and submissions Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) Notice Food and Drug Regulations
Applications and submissions Notice: Tablet Scoring of Subsequent-entry Pharmaceutical Products Notice Food and Drug Regulations
Applications and submissions Notice: Updates to the quality (chemistry and manufacturing) guidance: New drug submissions and abbreviated new drug submissions & the guidance document: Labelling of pharmaceutical drugs for human use documents Notice Agile regulations
Regulatory Notifying Health Canada of Foreign Actions - Guidance Document for Industry Guidance Food and Drug Regulations
Preparation Official Method: Conjugated Estrogens Guidance Food and Drug Regulations
Preparation Official Method: Determination of Flame Projection Guidance Food and Drug Regulations
Preparation Official Method: Determination of Net Contents Guidance Food and Drug Regulations
Preparation Official Method: Determination of the Disintegration Time of Tablets Guidance Food and Drug Regulations
Preparation Official Method: Thyroid Guidance Food and Drug Regulations
Opioids Opioid Warning Sticker and Patient Information Handout, and Risk Management Plans Guidance Food and Drug Regulations
Regulatory Patented Medicines List n/a
Clinical trials Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications Policy Food and Drug Regulations
Notice of compliance Post-notice of compliance changes Guidance n/a
Applications and submissions Priority Review List Food and Drug Regulations
Applications and submissions Product monograph guidance documents and notices List Food and Drug Regulations
Post-market Product Vigilance List Food and Drugs Act
Biologics QT/QTc Interval Prolongation List n/a
Applications and submissions Quality (chemistry and manufacturing) guidance: New Drug Submissions and Abbreviated New Drug Submissions Guidance Food and Drug Regulations
Clinical trials Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I)) Template Food and Drug Regulations
Clinical trials Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II)) Template Food and Drug Regulations
Clinical trials Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III) Template Food and Drug Regulations
Applications and submissions Questions and Answers - Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice FAQ Food and Drug Regulations
Labelling Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs - document FAQ Food and Drug Regulations
Applications and submissions Reconsideration of Final Decisions Notice Food and Drug Regulations, Natural Health Products Regulations
Applications and submissions Regulatory Enrolment Process (REP) List Food and Drugs Act
Labelling Revised Guidance Document: Acetaminophen Labelling Standard Guidance Food and Drug Regulations
Pharmacovigilance Risk classification guide for good pharmacovigilance practices observations (GUI-0063) Guide Food and Drug Regulations
DIN (Drug identification number) Summary - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales Guidance Food and Drug Regulations
Biologics Summary of changes: Lot Release Program for Schedule D (biologic) drugs for implementation Guidance Agile regulations
Applications and submissions Summary: Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs Guidance - summary Food and Drug Regulations
Labelling Summary: Guidance Document Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (effective April 1, 2020) Guidance - summary Food and Drug Regulations
Applications and submissions Templates on applications and submissions for drug products List n/a
Clinical trials Update: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties Notice Food and Drug Regulations
Applications and submissions Use of a Foreign-sourced Reference Product as a Canadian Reference Product Guidance Food and Drug Regulations
Reviews Use of foreign reviews List Food and Drugs Act

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2026-07-15