欧盟草药药品注册评价技术标准体系研究

Study on technical guidelines and standards for registration and evaluation of herbal medicinal products in European Union

欧盟在全球植物药市场的地位举足轻重,推动更多中成药尤其是复方产品进入欧盟药品市场,对中药国际化具有重要战略意义。立足中成药欧盟市场准入中的注册评价技术标准这一关键环节,从欧盟相关法律法规基础与技术标准体系构成,以及产品质量、安全与有效性评价技术要求等方面,系统剖析欧盟草药药品注册评价技术标准特点,并针对欧盟复方产品的要求进行专门讨论。研究结果对于我国深入认识欧盟草药药品监管体系内涵、搭建中欧植物药科学监管机制研究的“桥梁”具有良好学术价值,对指导和推动中成药开展欧盟药品注册工作具有积极地促进作用。

The European Union(EU) plays an important role in the global botanical medicine market,and promotes more Chinese patent medicine,especially compound products to enter the EU pharmaceutical market,which is of great strategic significance for the internationalization of traditional Chinese medicine(TCM).Based on the key link of the technical standards for registration and evaluation of Chinese patent medicine in EU market access,this paper systematically analyzes the characteristics of the technical guidelines and standards for the registration and evaluation of herbal medicinal products in EU from the aspects of the basis and core composition of relevant EU laws and technical regulations,as well as the technical requirements for product quality,safety and effectiveness evaluation,and specifically discusses the requirements for EU compound products.The research results have good academic value for China to further understand the connotation of the EU herbal medicine regulatory system and build a “bridge” for the research of the scientific regulatory mechanism of plant medicines in China and Europe,and have a positive role in guiding and promoting the development of pharmaceutical registration of proprietary Chinese patent medicines in the EU.