深度解析草药专论对中药欧盟注册的价值与重要性

草药专论(Community Herbal Monograph,CHM)是由欧盟药品监管当局组织制定,反映欧盟对草药安全与有效性科学评价意见及结论,并发挥促进欧盟草药药品领域技术协调作用的官方文件。作为欧盟层面对草药安全性与有效性评价的技术协调结果,CHM评价与建立在某种程度上和欧洲药品管理局(European Medicines Agency,EMA)负责审评的集中程序非常类似,与成员国药审局审评的成员国程序、分散程序及互认可程序共同构成了欧盟草药药品监管体系集中与分权并存的特点。CHM与传统草药药品在成员国的上市审批管理要求共同构成了2004/24/EC法令中有关传统草药药品在欧盟的上市审批框架,且CHM作为欧盟层面对草药的评价结论,在欧盟成员国的产品上市审批制度中具有重要地位与作用。然而,国内至今未能对CHM充分认识,更难以借助CHM促进中成药的欧盟注册进程。针对2004/24/EC法令CHM在传统草药药品上市审批中的核心价值进行系统解析,结合CHM在成员国传统草药药品上市批准实践中的应用情况分析,深入阐述CHM在欧盟草药药品上市审批过程中的价值与重要性,以期唤起国内业界对CHM的充分重视,并为中药欧盟注册提供重要参考。

Analysis on value of Community Herbal Monograph in registration of traditional Chinese medicinal products in Europe

The Community Herbal Monograph (CHM) is an official document which reflects the scientific opinion of European Medicines Agency (EMA) and plays an important role in technical harmonization of the herbal medicinal products. The role of CHM is very similar with the centralized procedure in the EU level as it represents the technical coordination results of the assessment about safety and efficacy of herbal medicine. The monograph and national procedure, decentralized procedure, and mutual recognition procedure together constitute the coexistence characteristic of centralization and decentralization of the EU medical legislation. The CHM and the traditional herbal medicine registration also constitute the core content of Directive 2004/24/EC in the EU and member state level respectively. And the CHM plays an important role in the registration of traditional herbal medicinal products in the EU member state. However, it has not yet been fully studied by domestic experts and scholars. This paper makes intensive studies on the value of CHM and analyzes the application of monograph in traditional herbal medicine registration. The purpose is to clarify the value and importance of CHM in the registration of traditional Chinese medicine in EU and to provide reference for the Chinese enterprises which are aspiring to open up the EU market.