International Council for Harmonisation (ICH) 

Guidelines: (Efficacy, Multidisciplinary, Quality, Safety)

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Information on ICH guidelines implemented by Health Canada

The tables below outline the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guideline(s) implemented by Health Canada. These guidelines have been developed by the appropriate ICH Expert Working Groups and have been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by the membership of ICH.

In implementing these ICH guidelines, Health Canada endorses the principles and practices described therein. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.

It is recognized that the scope and subject matter of current Health Canada guidance documents may not be entirely consistent with those of the ICH guidelines that are being introduced as part of our commitment to international harmonisation and the ICH Process. In such circumstances, Health Canada-implemented ICH guidelines take precedence.

Health Canada is committed to eliminating such discrepancies and will publish explanatory notices for stakeholders, where applicable. This will result in the amendment or, depending on the extent of revisions required, withdrawal of some Health Canada guidance documents.

Should you have any questions or comments regarding the contents of the ICH guidelines, please contact:

Health Canada - ICH Coordinator
E-mail: ich@hc-sc.gc.ca

Recently finalised ICH guidelines

This table lists ICH guidelines that have recently been finalised at ICH and are pending implementation or have either been implemented by Health Canada in the last 12 months.

Document Type of Notice File Number Additional Notes
Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Interim Implementation 20-113699-873 For more information, please see the October 9, 2020 Notice.
Q12: Pilot Programs Notice 21-115313-479 N/A
Q3C(R8): Impurities: Guideline for Residual Solvents Step 4 – Final Guideline 21-109767-280 This guideline was implemented on June 4, 2021
E8(R1): General Considerations for Clinical Studies Step 4 – Final Guideline 21-121043-747 This guideline was implemented on January 14, 2022
E14/S7B: Questions & Answers - Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Step 4 - Final Q&A Document 22-105019-395 This Q&A document was implemented on June 10, 2022

Efficacy guidelines

Documents and Links Implementation Date File Number

E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions

1995/06/01

H42-2/67-7-1995E

E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

E2A: Reminder for Sponsors

1995/06/01

2012/08/21

H42-2/67-8-1995E

12-113569-723

E2B(R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)

In the process of implementation

H164-33/2018E-PDF

E2B(R3): Q&A - Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

In the process of implementation

H164-33/2018E-PDF

E2C(R2): Guideline - Periodic Benefit-Risk Evaluation Report (PBRER)

E2C(R2): Health Canada Notice

2010/11/29

2013/04/09

10-123674-389

13-105055-393

E2C(R2): Q&A - Periodic Benefit-Risk Evaluation Report

2013/04/09

13-105055-393

E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

2011/03/02

978-1-100-17663-5

E2E: Pharmacovigilance Planning

2009/02/16

09-103644-626

E2F: Development Safety Update Report

E2F: Check list for Submitting Requested Development Safety Update Reports (DSUR) in Electronic Format

2012/12/20

N/A

12-122199-139

N/A

E3: Guideline - Structure and Content of Clinical Study Reports

1997/05/20

H42-2/67-10-1996E

E3: Q&A(R1) - Structure and Content of Clinical Study Reports

2015/12/18

15-113539-305

E4: Dose-Response Information to Support Drug Registration

1994/10/01

H42-2/67-4-1994E

E5(R1): Guideline - Ethnic Factors in the Acceptability of Foreign Clinical Data

2015/12/18

15-113552-719

E5: Q&A(R1) - Ethnic Factors in the Acceptability of Foreign Clinical Data

2016/01/04

15-113559-530

E6(R2): Good Clinical Practice

2019/04/03

19-105427-311

E7: Guideline - Studies in Support of Special Populations: Geriatrics

1994/10/01

H42-2/67-1-1994E

E7: Q&A - Studies in Support of Special Populations: Geriatrics

2015/06/16

15-107057-839

E8(R1): General Considerations for Clinical Studies

2022/01/14

21-121043-747

E9: Statistical Principles for Clinical Trials

2003/02/10

03-102451-780

E9(R1): Addendum - Statistical Principles for Clinical Trials

2020/07/21

20-109237-45

E10: Choice of Control Groups and Related Issues in Clinical Trials

2001/06/02

11-112316-337

E11(R1): Addendum - Clinical Investigation of Medicinal Products in the Pediatric Population

2018/04/05

18-103371-955

E14: Guideline - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

2006/04/05

06-106861-656

E14/S7B: Questions & Answers - Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential   2022/06/10 22-105019-395

E14/S7B: Health Canada Q&A Document Regarding ICH S7B and E14 Guidelines

2006/11/30

06-124711-745

E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories

2008/08/13

08-119122-123

E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions

2016/01/08

15-113833-472

E17: General Principles for Planning and Design of Multi-Regional Clinical Trials

2019/04/12

19-105427-311

E18: Genomic Sampling and Management of Genomic Data

2018/04/26

18-104323-973

Multidisciplinary guidelines

Documents and Links Implementation Date File Number

M1: MedDRA (Medical Dictionary for Regulatory Activities)

Health Canada MedDRA webpage

2008/01/01

N/A

M2: Electronic Standards for the Transfer of Regulatory Information (ESTRI)

N/A

N/A

M3(R2): Guideline - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

2016/01/21

15-113976-375

M3(R2): Q&A(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

2016/01/21

15-113993-89

M4: Common Technical Document (CTD)

Health Canada CTD webpage

2012/06/23

12-110850-902

M7(R1): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

2018/01/19

18-100716-962

M8: Electronic Common Technical Document (eCTD) - v4.0

Health Canada eCTD webpage

N/A

In the process of implementation

M9: Guideline - Biopharmaceutics Classification System-based Biowaivers

2020/08/26

20-109235-116

M9: Q&A - Biopharmaceutics Classification System-based Biowaivers

2020/08/26

20-109235-116

M9: Evaluation Template

N/A

N/A

Quality guidelines

Documents and Links Implementation Date File Number
Q1A(R2): Guideline - Stability Testing of New Drug Substances and Products 2003/09/25 03-118437-914
Q1B: Guideline - Stability Testing: Photostability Testing of New Drug Substances and Products 1999/02/12 H42-2/77-1998E
Q1C: Guideline - Stability Testing: Requirements for New Dosage Forms 1999/01/18 H42-2/78-1998E
Q1D: Guideline - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 2003/09/25 03-118449-498
Q1E: Guideline - Evaluation of Stability Data 2003/09/25 03-118451-122
Q2(R1): Guideline - Validation of Analytical Procedures: Text and Methodology 2015/06/05 15-106599-601
Q3A(R2): Guideline - Impurities in New Drug Substances 2015/06/05 15-106606-354
Q3B(R2): Guideline - Impurities in New Drug Products 2015/06/15 15-106634-508
Q3C(R8): Guideline - Impurities: Guideline for Residual Solvents 2021/06/04 21-109767-280
Q3D(R1): Guideline - Guideline for Elemental Impurities 2019/05/31 19-110103-506
Q4B: Guideline - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions 2010/09/29 10-120634-491
Q4B: Annex 1(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter 2010/10/13 10-121155-764
Q4B: Annex 2(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter 2010/10/13 10-121172-973
Q4B: Annex 3(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter 2010/10/26 10-121191-626
Q4B: Annex 4A(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter 2010/10/13 10-121518-692
Q4B: Annex 4B(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter 2010/10/18 10-121745-378
Q4B: Annex 4C(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter 2010/10/20 10-121780-106
Q4B: Annex 5(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter 2010/10/22 10-121831-758
Q4B: Annex 6 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter 2015/05/29 15-106278-499
Q4B: Annex 7(R2) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter 2010/10/22 10-121855-881
Q4B: Annex 8(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter 2010/10/26 10-121878-840
Q4B: Annex 9(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter 2010/10/26 10-121949-582
Q4B: Annex 10(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter 2010/10/26 10-122178-463
Q4B: Annex 11 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter 2015/05/29 15-106291-302
Q4B: Annex 12 – Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter 2015/06/03 15-106304-540
Q4B: Annex 13 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders General Chapter 2015/05/29 15-106311-850
Q4B: Annex 14 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter 2015/05/29 15-106315-995
Q5A(R1): Guideline - Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 2011/01/05 H42-2/67-18-2000E
Q5B: Guideline - Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of R-DNA Derived Protein Products 2001/01/05 H42-2/67-19-2000E
Q5C: Guideline - Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products 2001/01/05 H42-2/67-20-2000E
Q5D: Guideline - Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/ Biological Products 2001/01/05 H42-2/67-21-2000E
Q5E: Guideline - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process 2015/06/15 15-107053-353
Q6A: Guideline - Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances 2016/01/29 16-100136-12
Q6B: Guideline - Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 2001/12/20 01-118655-734
Q7: Guideline - Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients 2002/12/07 Guide GUI-0104
Q7: Q&A - Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients 2016/06/10 16-106660-852
Q8(R2): Guideline - Pharmaceutical Development 2016/02/11 16-101390-659
Q9: Guideline - Quality Risk Management 2016/02/05 16-100155-230
Q10: Guideline - Pharmaceutical Quality System 2016/02/15 16-101419-273
Q8, Q9 and Q10: Q&As(R4) 2016/02/05 16-100246-83
Q11: Guideline - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) 2016/02/12 16-100199-626
Q11: Q&A - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) 2018/04/04 18-103369-70
Q12: Guideline - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management In the process of implementation 20-113699-873

Safety guidelines

Documents and Links Implementation Date File Number
S1: Proposed Change to Guideline - Rodent Carcinogenicity Testing of Pharmaceuticals - Regulatory Notice Document 2015/12/22 N/A
S1A: Need for Carcinogenicity Studies of Pharmaceuticals 2002/12/23 02-122028-691
S1B: Testing for Carcinogenicity of Pharmaceuticals 2000/03/24 H42-2-67-14-1999E
S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals 2016/06/10 16-106598-127
S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use 2016/01/21 15-114028-981
S3A: Guideline - Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 2002/12/23 02-122028-691
S3A: Q&A - Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling 2018/04/26 18-104328-485
S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies 2002/12/23 02-122028-691
S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) 2000/03/24 H42-2/67-17-1999E
S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals 2020/08/10 20-109240-987
S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 2016/01/22 15-114041-80
S7A: Safety Pharmacology Studies for Human Pharmaceuticals 2006/03/31 06-104501-828
S7B: The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals 2006/04/13 06-106829-31
S7B/E14: Questions & Answers - Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential 2022/06/10 22-105019-395
S7B/E14: Health Canada Q&A Document Regarding ICH S7B and E14 Guidelines 2006/11/30 06-124711-745
S8: Immunotoxicity Studies For Human Pharmaceuticals 2016/01/22 15-114056-97
S9: Guideline - Nonclinical Evaluation for Anticancer Pharmaceuticals 2016/01/22 15-114066-970
S9: Q&A - Nonclinical Evaluation for Anticancer Pharmaceuticals 2018/06/26 18-107442-162
S10: Photosafety Evaluation of Pharmaceuticals 2016/01/22 15-114073-949
S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines 2020/08/17 20-109241-110
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