Safety

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

• S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals [2016-01-22]

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]
  • Health Canada Question and Answer Document Regarding the ICH S7B and E14 Guidances [2006-11-30]
  • QT/QTc Interval Prolongation

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

• S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines [2020-08-17]

Cross-cutting Topics

• 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]
• M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2016-01-21]