技术导则

2007-Guideline on the non-clinical investigation of the dependence potential of medicinal products

2026-09-03

2007-Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

2026-09-03

2007-Guideline on reporting the results of population pharmacokinetic analyses

2026-09-03

2007-Guideline on potency testing of cell based immunotherapy__medicinal products for the treatment of cancer

2026-09-03

2007-Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - First version

2026-09-03

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

2026-09-03

2007-Guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy

2026-09-03

2007-Guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk - Revision 1

2026-09-03

2007-General principles processing joint FDA EMEA Voluntary Genomic Data Submissions (VGDSs) within the framework of the confidentiality arrangement

2026-09-03

2007-Draft guideline on the specification limits for residues of metal catalysts

2026-09-03

2007-Draft guideline on the requirements for clinical documentation for Orally Inhaled Products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatme...

2026-09-03

2007：Draft guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases

2026-09-03