학술논문
中国、美国和欧盟植物药注册法规和技术要求比较研究 / A Comparative Study of Botanical Drug Registration Regulations and Technical Requirements in China,the USA,and the European Union
Document Type
Academic Journal
Author
Source
中国食品药品监管 / China Food Drug Administration. (12):120-129
Subject
Language
Chinese
ISSN
1673-5390
Abstract
本文基于我国国家药品监督管理局(NMPA)、美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)颁布的植物药注册法规及相关指南,从植物药管理范畴、药学研究、非临床研究和临床研究等4个方面开展比较研究,总结归纳3个国家和地区植物药注册管理和技术要求之间的异同点,为中药以植物药身份进入欧美主流市场的研究与申报探索新思路.
This study is based on botanical drug registration regulations and related guidelines issued by China's NMPA,the US FDA,and the EU EMA.It conducts comparative studies in four aspects:botanical drug management scope,pharmaceutical research,non-clinical,and clinical research.The study summarizes the similarities and differences in the registration management and technical requirements of botanical drugs among these three countries and regions,aiming to explore new path for the research and application of botanical drugs in mainstream markets in Europe and America.
This study is based on botanical drug registration regulations and related guidelines issued by China's NMPA,the US FDA,and the EU EMA.It conducts comparative studies in four aspects:botanical drug management scope,pharmaceutical research,non-clinical,and clinical research.The study summarizes the similarities and differences in the registration management and technical requirements of botanical drugs among these three countries and regions,aiming to explore new path for the research and application of botanical drugs in mainstream markets in Europe and America.