Safety
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Should you have any questions or comments regarding the content of the guidance documents found on this page please contact:
Health Canada – ICH Coordinator
Email: HPFB_ICH_DGPSA@hc-sc.gc.ca
S1: Carcinogenicity Studies
- S1 Regulatory Notice Document [2016-06-10]
- S1A: Need for Carcinogenicity Studies of Pharmaceuticals [2002-12-23]
- S1B: Testing for Carcinogenicity of Pharmaceuticals [2000-03-24]
- S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals and Limit Dose [2016-06-10]
S2: Genotoxicity Testing
- S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use [2016-01-21]
S3: Toxicokinetics and Pharmacokinetics
- S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies [2002-12-23]
- S3A: Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling [2018-04-26]
- S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies [2002-12-23]
S4: Toxicity Testing
- S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) [2000-03-24]
S5: Reproductive Toxicity
- S5(R3): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility [2020-08-10]
S6: Biotechnological Products
S7: Pharmacology Studies
- S7A: Safety Pharmacology Studies for Human Pharmaceuticals [2006-03-31]
- S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [2006-04-05]
S8: Immunotoxicity Studies
- S8: Immunotoxicity Studies For Human Pharmaceuticals [2016-01-22]
S9: Nonclinical Evluaton for Anticancer Pharmaceuticals
- S9: Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals, Questions and Answers [2018-06-26]
- S9: Nonclinical Evaluation for Anticancer Pharmaceuticals [2016-01-22]
S10: Photosafety Evaluation
- S10: Photosafety Evaluation of Pharmaceuticals [2016-01-22]
S11: Nonclinical Safety Testing
Cross-cutting Topics
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