技术导则

2004：Note for guidance on the evaluation of the pharmacokinetics of medical products in patients with impaired renal function

2026-06-09

2004：First cases of bovine spongiform encephalopathy in the United States (USA) and Canada： Risk assessment of ruminant materials originating from the USA and Canada

2026-06-09

2004：Concept paper on the development of a guideline on viral safety evaluation of biotechnological products to be used in clinical trials

2026-06-09

2004：CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment - Revision 1

2026-06-09

2003：Points to consider on xenogeneic cell therapy medicinal products

2026-06-09

2002：Points to consider on the need for assessment of reproductive toxicity of human insulin analogues

2026-06-09

2002：Note for guidance on specification limits for residues of metal catalysts

2026-06-09

2002：Note for guidance on production and quality control of animal immunoglobins and immunosera for human use

2026-06-09

2002：CPMP position statement on non-remunerated and remunerated donors： safety and supply of plasma-derived medicinal products

2026-06-09

2001：Points to consider on the manufacture and quality control of human somatic cell therapy medicinal products

2026-06-09

2001：Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues

2026-06-09

2001：Note for guidance on the quality, preclinical and clinical aspects of gene transfer of medicinal products

2026-06-09