摘要
随着科技进步,抗体类药物等新型生物制剂成为兽药研发和注册热点,其特点与化学药品和传统疫苗均有差异,为解决注册法规与产品注册需求不相称的问题,欧盟历经10年修订注册法规,发布了2019/6号指令,其附录II增加了新型生物制剂的注册资料要求。2024年发布了兽药产品分类问答文件,以决策树形式明晰了注册分类。本文综述了欧盟关于兽用抗体类药物注册的相关文件,为我国该类产品的注册分类和注册资料要求提供参考。
With the advancement of technology,new biological products such as antibody drugs have become hotspots in the research and development of veterinary drugs.Their characteristics differ from those of chemical pharmaceuticals and traditional vaccines.To address the lag between registration regulations and product registration demands,the European Union spent 10 years revising registration regulations and issued Regulation 2019/6.Its appendix II has added requirements for the registration information of antibody drugs.In 2024,a Q&A document on the classification of veterinary drug products was released,clarifying the registration classification in the form of a decision tree.This article reviews the relevant documents of the European Union regarding the registration of veterinary antibody drugs,providing a reference for the registration classification and registration data requirements of antibody products in China.
作者
苏富琴
徐倩
李丹
梁先明
李翠
印春生
谷红
SU Fu-qin;XU Qian;LI Dan;LIANG Xian-ming;LI Cui;YIN Chun-sheng;GU Hong(China Institute of Veterinary Drug Control,Beijing 100081,China)
出处
《中国兽药杂志》
2025年第10期56-61,共6页
Chinese Journal of Veterinary Drug
关键词
欧盟
抗体类药物
注册分类
注册资料要求
European Union
Antibody drugs
Registration category
Requirements for registration information
