Guidance Documents – Applications and submissions – Drug products
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Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing drug submissions when seeking an approval to sell a pharmaceutical drug product in Canada.
A
- Acetaminophen Labelling Standard
- Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
- Adverse Reactions:
- Antiseptic Drugs for Human-Use
- Asthma: Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma
B
- Bioavailability and Bioequivalence
- Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document
- Conduct and Analysis of Comparative Bioavailability Studies
- Comparative Bioavailability Standards: Formulations use for System Effects
- Data Requirements for Safety and Effectiveness of Subsequent Market Entry Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis
- Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format (draft)
- ICH M9: Guideline on Biopharmaceutics Classification System-based Biowaivers
- ICH M9: Q&A on Biopharmaceutics Classification System-based Biowaivers
C
- Canadian Reference Product - Use of a Foreign-sourced Reference Product as a Canadian Reference Product
- Cannabis - Health products containing cannabis or for use with cannabis
- Certificate of Supplementary Protection Regulations (CSP)
- Chemical Entity Products/Quality
- Clinical Trials
- Guidance on applications for COVID-19 drug clinical trials under the Regulations
- Notice to Stakeholders - Clarification of Requirements under the Food and Drug Regulations when Conducting Clinical Research with Cannabis
- Applications for drug clinical trials under the Interim Order: Guidance document
- Clinical Trial Applications
- Clinical Trials Manual
- Clinical Trial Applications
- Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans
- Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications for Pharmaceuticals
- Template: Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I))
- Template: Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II)) Template: Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II))
- Template: Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase III (QOS-CE (CTA - Phase III))
- Update for Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties - Notice
- Notice: Update to Clinical Trial Site Information Form
- Standards for Clinical Trials in Type 2 Diabetes in Canada
- Inclusion of Women in Clinical Trials
- ICH M4: Common Technical Document
- Common Electronic Submissions Gateway (CESG)
- Confidential Business Information - Disclosure under Paragraph 21.1(3)(c) of the Food and Drugs Act
- Cost Recovery guidance documents for drug products and applications and submissions
- Notice: Guidance Document Updates to Reflect New Fees and Policies for April 1, 2020
D
- Data Protection under C.08.004.1 of the Food and Drug Regulations
- Databases - Drug and Medical Devices
- Diabetes: interim approach for evaluating cardiovascular risk for new antidiabetic therapies to treat Type 2 diabetes mellitus - Notice
- Disinfectants
- Disinfectant Drugs
- Management of Disinfectant Drug Applications [in effect until March 31, 2020]
- Management of Disinfectant Drug Applications [in effect April 1, 2020]
- Safety and Efficacy Requirements for Contact Lens Disinfectants
- Safety and Efficacy Requirements for Hard Surface Disinfectant Drugs
- Safety and Efficacy Requirements for High-level Disinfectants and Sterilants for Use on Reusable Semi-critical and Critical Medical Devices
- Drug Facts Table for Non-prescription Drugs
- Drug Identification Number (DIN)
- Preparation of DIN Submissions
- Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) [in effect until March 31, 2020]
- Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) [in effect April 1, 2020]
- Regulatory Requirements for DINs
- Drug Submission Status Requests
- Drugs Currently Regulated as New Drugs
F
- Filing Submissions Electronically
- Food and Drugs Act
- Notifying Health Canada of Foreign Actions
- Foreign Reviews
G
- Guidance Document on the Distribution of Drugs as Samples [2020-04-29]
- Good Guidance Practices
- Good Manufacturing Practices
H
- Human-Use Antiseptic Drugs
- Haemodialysis Solutions
- Helicobacter pylori
- Hepatotoxicity - Pre-market Evaluation of Hepatotoxicity in Health Products
- Hormone Replacement Therapy
I
- Inhalers
- Guidance to Establish Equivalent or Relative Potency of Safety and Efficacy of a Second Entry Short-Acting Beta2-Agonist Metered Dose Inhaler
- Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Market Entry Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis
- International Council for Harmonisation (ICH)
L
- Labelling
- Drug Facts Table for Non-prescription Drugs
- Labelling of Pharmaceutical Drugs for Human Use
- Labelling Requirements for Non-prescription Drugs
- Non-prescription Drugs: Labelling Standards - Drug Product
- Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products
- Good Label and Package Practices Guide for Prescription Drugs
- Look-alike Sound-alike (LA/SA) Health Product Names: Marketed Health Product Name Assessment
M
- Master Files (MFs) - Procedures and Administrative Requirements
- Management of Drug Submissions [in effect until March 31, 2020]
- Management of Drug Submissions and Applications (formerly Management of Drug Submissions) [in effect April 1, 2020]
N
- New Drugs
- Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice
- Non-prescription Drugs: Category IV Monographs
- Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
- Notice of Compliance with Conditions
O
- Official Methods
- Opioids
- Oral Contraceptives
P
- Patented Medicines
- Submission of Pharmacogenomic Information
- Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs [in effect April 1, 2020]
- Pharmacometrics - Use in drug submissions and clinical trial applications: Policy statement
- Plain Language Labelling Regulations for Non-prescription Drugs and Contact Lens Disinfectants - Questions and Answers [in effect until March 31, 2020]
- Plain Language Labelling Regulations for Non-prescription Drugs - Questions and Answers [in effect April 1, 2020]
- Post-Drug Identification Number (DIN) Changes
- Post-Notice of Compliance Changes
- Consultation: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes - Quality, for stakeholder consultation
- Notice: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes - Quality, for stakeholder consultation
- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document [in effect April 1, 2020]
- Post-Notice of Compliance (NOC) Changes: Framework Document [in effect April 1, 2020]
- Post-Notice of Compliance Changes: Quality Document
- Updated - Notice regarding the Post-Notice of Compliance (NOC) Changes: Notices of Change: Level III Form
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form [in effect April 1, 2020]
- Pre-market Evaluation of Hepatotoxicity in Health Products
- Prescription status - Determining Prescription Status for Human and Veterinary Drugs
- Priority Review
- Product Monograph
- Notice - Product Monograph Implementation Plans
- Updated: Notice - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products
- Health Canada changes filing requirements for product monographs: Notice
- Draft Guidance Document Preparation of the PM in XML format (available upon request via email: Click here to submit an email request to no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format' is in the subject line of the email
- Consultation on the changes to the 2020 product monograph guidance and master template
- Product Vigilance
Q
R
- Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions
- Reconsideration of Final Decisions
- Regulatory Enrolment Process
- Regulatory Requirements for DINs
- Review of Drug Brand Names
S
- Safety: Testing for Carcinogenicity of Pharmaceuticals
- Schedule A and Section 3 to the Food and Drugs Act
- Source Establishment - Reporting Adverse Reactions to Human Cells, Tissues and Organs
- Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)
- Switches
T
- Tablet Scoring of Subsequent-entry Pharmaceutical Products
- Drug Submissions Relying on Third-Party Data (Literature and Market Experience)
U
V
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