ICH指导原则共180条
安全性
Pharmacokinetics_ Guidance for Repeated Dose Tissue Distribution Studies
安全性
Note for Guidance on Toxicokinetics_ The Assessment of Systemic Exposure in Toxicity Studies
安全性
Nonclinical Evaluation for Anticancer Pharmaceuticals
安全性
Need for Carcinogenicity Studies of Pharmaceuticals
安全性
Immunotoxicity Studies for Human Pharmaceuticals
安全性
Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
安全性
Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
安全性
Dose Selection for Carcinogenicity Studies of Pharmaceuticals
安全性
Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility
多学科综合
药物进行人体临床试验和上市许可申请的非临床安全性研究指导原则
多学科综合
人用药物注册申请的通用技术文件：有效性
多学科综合
The Common Technical Document for the Registration of Pharmaceuticals for Human Use_Efficacy
多学科综合
The Common Technical Document for the Registration of Pharmaceuticals for human Use_ Safety
多学科综合
The Common Technical Document for the Registation of Pharmaceuticals for Human Use_ Quality
多学科综合
Revision of M4e Guideline on Enhancing the Format and Structure of Benefit-risk Information in Ich
多学科综合
Questions & Answers_ Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
多学科综合
Organisation of the Common Technical Document For The Registration of Pharmaceuticals for human use
多学科综合
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
多学科综合
Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk