title: Future development of global regulations of Chinese herbal products.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacology, University of Cambridge, UK. tpf1000@cam.ac.uk
authors.forename: Tai-Ping
authors.initials: TP
authors.lastname: Fan
authors.forename: Greer
authors.initials: G
authors.lastname: Deal
authors.forename: Hoi-Lun
authors.initials: HL
authors.lastname: Koo
authors.forename: Daryl
authors.initials: D
authors.lastname: Rees
authors.forename: He
authors.initials: H
authors.lastname: Sun
authors.forename: Shaw
authors.initials: S
authors.lastname: Chen
authors.forename: Jin-Hui
authors.initials: JH
authors.lastname: Dou
authors.forename: Valery G
authors.initials: VG
authors.lastname: Makarov
authors.forename: Olga N
authors.initials: ON
authors.lastname: Pozharitskaya
authors.forename: Alexander N
authors.initials: AN
authors.lastname: Shikov
authors.forename: Yeong Shik
authors.initials: YS
authors.lastname: Kim
authors.forename: Yi-Tsau
authors.initials: YT
authors.lastname: Huang
authors.forename: Yuan Shiun
authors.initials: YS
authors.lastname: Chang
authors.forename: William
authors.initials: W
authors.lastname: Jia
authors.forename: Alberto
authors.initials: A
authors.lastname: Dias
authors.forename: Vivian Chi-Woon
authors.initials: VC
authors.lastname: Wong
authors.forename: Kelvin
authors.initials: K
authors.lastname: Chan
mesh_terms: D000349:Africa; D001208:Asia; D001315:Australia; D001938:Brazil; D002681:China; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D004365:Drugs, Chinese Herbal; D005062:European Union; D005544:Forecasting; D033161:Government Regulation; D006801:Humans; D038622:Internationality; D007880:Legislation, Drug; D007881:Legislation, Food; D008516:Medicine, Chinese Traditional; D008517:Phytotherapy; D010946:Plants, Medicinal; D014481:United States
chemical_list: D004365:Drugs, Chinese Herbal