Department of Pharmacology, University of Cambridge, UK.
J Ethnopharmacol. 2012 Apr 10;140(3):568-86. doi: 10.1016/j.jep.2012.02.029. Epub 2012 Feb 25.
GP-TCM is the first EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. One of the key deliverables of the Work Package 7 in GP-TCM was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies. The paper aims to collate data and draw comparison of these regulations. Case studies are also presented to illustrate the problems involved in registering TCM products in different regions worldwide.
A collaborative network task force was established during the early stage of the GP-TCM project and operated through exchanges, teleconferences and focused discussions at annual meetings. The task force involved coordinators, academics who are actively involved with R&D of Chinese herbal medicines, experts on monographic standards of Chinese materia medica, representatives from regulatory agencies, experts from industries in marketing Chinese medicines/herbal medicines and natural products. The co-ordinators took turns to chair teleconferences, led discussions on specific issues at AGM discussion sessions, at joint workshops with other work-packages such as WP1 (quality issues), WP3 (toxicology issues) and WP6 (clinical trial issues). Collectively the authors were responsible for collating discussion outcomes and updating written information.
A global overview of regulations on herbal registration has been compiled during the three years of the consortium. The regulatory requirements for registration of herbal products in the EU and China were compared, and this is extended to other regions/countries: Africa, Australia, Brazil, Canada, Japan, Russia, South Korea, Taiwan, and the United States. A wide variation of the regulations for the categories of herbal products exists: food (functional food, novel foods, dietary food for special medical purpose, foods for particular nutritional use, food supplement); cosmetic, traditional herbal medicine products; herbal medicines for human use and veterinary use.
The regulatory issues for registration of herbal products are complicated among the countries and regions worldwide. The information summarised in the text is for reference only. Some regulations which are presented in this review are still in legislation process and may change in due course. Before taking any regulatory action, readers are advised to consult current official legislation and guidance and/or to seek appropriate professional advice. The lessons learnt from global regulation of TCM will provide valuable insights for regulation of other traditional medicine such as Ayurveda and Unani medicine, as well as other forms of indigenous medicine. The WHO is well placed to co-ordinate a consultation process with the aim of putting forward suggestions for harmonisation to key regulatory agencies.
GP-TCM 是第一个由欧盟资助的协调行动联盟，致力于传统中药（TCM）研究。GP-TCM 第 7 工作包的主要交付成果之一是调查全球监管机构列出的 TCM 产品注册现有要求的信息。本文旨在整理数据并比较这些法规。也提出了案例研究来说明在世界不同地区注册 TCM 产品所涉及的问题。
在 GP-TCM 项目的早期阶段，成立了一个协作网络工作组，通过交流、电话会议和年度会议上的重点讨论进行运作。该工作组涉及协调员、积极参与中草药研发的学者、中药专论标准专家、监管机构代表、中药/草药和天然产品营销行业专家。协调员轮流主持电话会议，在年度会议讨论会议上就具体问题进行讨论，与 WP1（质量问题）、WP3（毒理学问题）和 WP6（临床试验问题）等其他工作包联合举办研讨会。作者共同负责整理讨论结果并更新书面信息。
在联盟的三年中，已经编制了草药注册全球概况。比较了欧盟和中国草药产品注册的监管要求，并将其扩展到其他地区/国家：非洲、澳大利亚、巴西、加拿大、日本、俄罗斯、韩国、台湾和美国。草药产品类别的监管要求差异很大：食品（功能性食品、新型食品、特殊医疗用途膳食食品、特殊营养用途食品、食品补充剂）；化妆品、传统草药产品；人用草药和兽用草药。
世界范围内各国和地区的草药产品注册监管问题复杂。本文总结的信息仅供参考。本文综述中提出的一些法规仍在立法过程中，可能会在适当的时候发生变化。在采取任何监管行动之前，建议读者咨询当前的官方立法和指南，并/或寻求适当的专业建议。从 TCM 的全球监管中吸取的经验教训将为其他传统医学（如阿育吠陀和尤纳尼医学）以及其他形式的本土医学的监管提供宝贵的见解。世界卫生组织有能力协调一个磋商过程，旨在向主要监管机构提出协调建议。
