欧盟草药药品监管模式对中国中药注册管理的启示＊

对药品实行注册管理制度是确保公众健康的全球通用的监管措施。中药作为承载中医药理论与用药实践的主要载体,对中药产品的注册管理又具有其特殊性。2017年正式实施的《中医药法》提出了建立符合中医药特点管理制度的发展方针,研究制定配套文件或修订现行规章以适应衔接其立法精神是当前重要的现实问题之一。欧盟在植物药监管领域取得了良好成效,本文旨在系统分析欧盟对其注册管理的法规体系,深入剖析其监管特点和对中国中药注册管理的启示,以期为当前《中医药法》背景下中药监管制度的改革提供参考。

Enlightenments of the European Herbal Medicinal Product Regulation Model to the Administration of TCM in China

To manage medicinal products by registration is a universal regulatory measure to ensure public health. Traditional Chinese medicine (TCM) is an important carrier of TCM theory and clinical practice. The registration management of TCM products has its own particularity. In 2017, the Law of the People s Republic of China on TCM has put forward the development policy of TCM which should conform to the TCM characteristics. It not only marks a new development period for TCM industry, but also poses new challenges to the registration management of TCM in China. There is an urgent need to study and formulate the supporting documents or revise existing regulations to adapt to the spirit of the law. The European Union (EU) has got great achievement in the field of herbal medicinal regulation since the introduction of Directive 2004/24/EC. This paper made a systematic review of the legislative system of European herbal medicinal product. The main European regulatory characteristics and the enlightenments to administration of TCM products in China were deeply analyzed. The purpose is to provide reference for the reform of administration of TCM under background of the law of the People s Republic of China on TCM.