College of Pharmacy, Chengdu University of Traditional Chinese Medicine, No.1166 Liutai Avenue, Wenjiang District, Chengdu 610000, China.
College of Pharmacy, Chengdu University of Traditional Chinese Medicine, No.1166 Liutai Avenue, Wenjiang District, Chengdu 610000, China.
Phytomedicine. 2018 Mar 15;42:219-225. doi: 10.1016/j.phymed.2018.03.048. Epub 2018 Mar 19.
The European Union (EU) has created a regulatory framework for herbal medicinal products (HMPs) since the enforcement of Directive 2004/24/EC. Substantial achievements have been made, with 1719 traditional use marketing registrations (TURs) and 859 well-established use marketing authorizations (WEU-MAs) for HMPs granted by the end of 2016. Apparently, the European regulation model has worked out well and in that the essential feature is the use of EU herbal monographs into those granted WEU-MAs and TURs.
A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies.
A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected.
The evaluation of applications by National Competent Authorities (NCAs) at a national level together with the assessment of EU monographs by the Committee on Herbal Medicinal Products (HMPC) at the European level constitute the European regulation framework for HMPs. As the scientific opinion about the safety and efficacy of HMPs from HMPC, the EU herbal monographs have been given a constitutional-based meaning to the TURs and WEU-MAs of HMPs and play a supportive function in the marketing procedure in Member States.
The European framework has provided a powerful regulation model for harmonization of scientific assessment and facilitation of product marketing. For the pharmaceutical industries particularly those outside the EU, optimal use of the EU herbal monograph in their marketing procedure in Europe could be of great benefit. Furthermore, this model is well worth learning from for other countries and regions outside the EU to help the establishment of legislation in countries with strong traditional use of herbal remedies and contribute to the safe use of traditional herbal medicine.
自 2004/24/EC 指令实施以来，欧盟（EU）已为草药药品（HMPs）创建了监管框架。截至 2016 年底，已授予 1719 项传统使用营销注册（TURs）和 859 项良好使用营销授权（WEU-MAs），取得了实质性的成果。显然，欧洲监管模式运行良好，其基本特征是将欧盟草药专论用于授予 WEU-MAs 和 TURs 的 HMPs。
对 HMPs 的欧洲监管模式以及该模式中的欧盟草药专论部分进行系统分析，以帮助理解欧盟立法，特别是对欧盟以外感兴趣的各方，之后，为制药公司在欧洲市场的 HMPs 注册决策以及在草药疗法使用传统强大的国家建立立法提供帮助。
在 PubMed、ScienceDirect、欧洲药品管理局网站和药品管理机构负责人网站上进行了检索（截至 2017 年 12 月），并收集了欧盟 HMPs 监管的现有信息。
国家主管当局（NCAs）在国家一级对申请的评估，以及草药药品委员会（HMPC）在欧洲一级对欧盟专论的评估，构成了 HMPs 的欧洲监管框架。作为 HMPC 对 HMPs 的安全性和有效性的科学意见，欧盟草药专论已赋予 HMPs 的 TURs 和 WEU-MAs 宪法意义，并在成员国的营销程序中发挥支持作用。
该欧洲框架为协调科学评估和促进产品营销提供了强有力的监管模式。对于制药行业，特别是欧盟以外的制药行业，在其在欧洲的营销程序中最佳利用欧盟草药专论将带来巨大的好处。此外，该模式值得欧盟以外的其他国家和地区借鉴，以帮助草药疗法使用传统强大的国家建立立法，并有助于传统草药的安全使用。
