技术导则

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

2006：Guideline on similar biological medicinal products containing Biotechnology-derived proteins as active substance： Non-clinical and clinical issues

2026-06-27

2006：Guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species

2026-06-27

2006：Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors

2026-06-27

2006：Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorization (bibliographical and mixed applications) and in applications for simplified registration - First version

2026-06-27

2006：Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorization (bibliographical and mixed applications) and in applications for simplified registration - First version

2026-06-27

2006：Guideline on non-clinical and clinical development of medicinal products for the treatment of nausea and vomiting associated with cancer chemotherapy

2026-06-27

2006：Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)

2026-06-27