第5版《欧洲药典》对于如何应对许可申请和ICH关于纯度限度的规定和通则方面的要求,给使用者提供了一个完整的、条理清晰的方法。《欧洲药典》的内容包括活性成分,辅料,所有化学、动物、人或植物来源的药用物质或制剂,抗生素以及剂型和容器,同样适用于生物制品、血液和血浆制品 The requirements of the European Pharmacopoeia of the 5th edition on how to deal with licensing applications and ICH’s requirements and general rules on purity limits provide users with a complete and well-organized approach. The content of the European Pharmacopoeia includes active ingredients, excipients, all chemical, animal, human or plant-derived pharmaceutical substances or preparations, antibiotics and dosage forms and containers, as well as biological products, blood and plasma products.