技术导则

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

2006：Draft reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products

2026-06-27

2006：Draft guideline on virus safety evaluation of biotechnological investigational medicinal products

2026-06-27

2006：Draft guideline on the development of new medicinal products for the treatment of ulcerative colitis

2026-06-27

2006：Draft guideline on reporting the results of population pharmacokinetic analyses

2026-06-27

2006：Draft guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy

2026-06-27