技术导则

2005：Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOS) (module 1.6.2)

2026-06-13

2005：Draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

2026-06-13

2005：Draft concept paper on the development of a guideline on the non-clinical__Studies prior to clinical use of gene therapy medicinal products

2026-06-13

2005：Concept paper on guidance on the approach on how to demonstrate whether a substance is capable of pharmacological action or not

2026-06-13

2005：CHMP SWP reflection paper on the assessment of the genotoxic potential of antisense oligodeoxynucleotides

2026-06-13

2004：VICH GL37： Safety of veterinary drugs in human food repeat-dose (Chronic) toxicity testing - Step 7

2026-06-13

M3(R2)指导原则：问答(R2)文件

2026-06-11

M3(R2) Questions & Answers

2026-06-11

M3(R2)：支持药物进行临床试验和上市的非临床安全性研究指导原则

2026-06-11

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

2026-06-11

2004：VICH GL31： Safety studies for veterinary drug residues in human food： Repeat-dose (90) toxicity testing - Step 7

2026-06-09

2004：VICH GL23： Safety studies for veterinary drug residues in human food： Genotoxicity studies - Step 7

2026-06-09