技术导则

2007：Draft guideline on the assessment of genotoxic constituents in herbal substances／preparations

2026-09-03

2007：Draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products - First version

2026-09-03

2007：Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - First version

2026-09-03

2007：Draft guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process. Non-clinical and clinical issues

2026-09-03

2007：Concept paper on the revision of the points to consider on xenogeneic cell therapy medicinal products

2026-09-03

2007：Concept paper on the development of a guideline on the quality,Preclinical and clinical aspects of medicinal products containing genetically modified cells - First version

2026-09-03

2007：Concept paper on the development of a Guideline on clinical monitoring and follow-up of patients exposed to gene therapy／gene transfer medicinal products

2026-09-03

2006：Submission of comments on Guideline on Similar Biological Medicinal Products containing biotechnology derived products as active substance： non-clinical and clinical issues Annex： recombinant__Erythropoietin containing p...

2026-06-27

2006：International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations：General principles to address the risk of inadvertent germline integration of gene th...

2026-06-27

2006：Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population

2026-06-27

2006：Guideline on the limits of genotoxic impurities

2026-06-27

2006：Guideline on the environmental risk assessment of medicinal products for human use - First version

2026-06-27