1、 Traditional medicine is one of the fastest growing industry.More than 60%of the European population use traditional medicine.With 44.5%of the world traditional medicine market and 500 million people,EU represents a tremendous opportunity for traditional Chinese herbal products shenzhou pefots 传统药品是
2、当今世界发展最快的传统产业，据统计有60%以上的欧洲人使用传统药品，欧洲占全球草药市场的44.5%的份额。现在欧盟扩大到27个国家，总人口近5亿，超过北美自由贸易区，成为全球最大的贸易市场，给中药制品在欧盟流通带来了更多便利。With thousands of years of experience and modern scientific research,TCM has withstood the test of time.TCM has proved to be effective in the prevention and treatment of diseases and well
3、-being.Not only has it made a great contribution to the health and well-being of the Chinese people,it also plays an increasingly important role in the health and well-being of people elsewhere.shenzhou pefots 经过几千年实践积累了丰富经验的中医药学，对防治疾病和养生保健都具有明确的疗效，它不仅为中国人民的健康事业做出了伟大的贡献，而且在欧洲医疗保健领域中也表现出它的独特作用和巨大潜力。s
4、henzhou pefots The Chinese Ministry of Health has signed the Memorandum of Understanding with the health authorities of 14 European countries,including Italy,Ireland,Austria,Denmark,Ukraine,Moldova,Croatia,Norway,and Bulgaria.中国卫生部已经与意大利、爱尔兰、奥地利、丹麦、乌克兰、摩尔多瓦、克罗地亚、挪威、保加利亚等 14个欧洲国家和地区的卫生部签署了谅解备忘录。shenz
5、hou pefots There are over 120,000 TCM practitioners and acupuncturists in Europe.Each year over 5,000 TCM students graduate from about 300 TCM training schools in Europe.More than 5 million people in Europe visit TCM practitioners each year in Europe.There are over 300 TCM products distributors all
6、over Europe.据不完全统计，欧洲目前有中医师、针灸师 12万之多，欧洲每年中医药应诊患者已超过500万人次。欧洲现有中医教学机构300多所，每年向各国输送5000多名中医药人员。欧洲各国现有中医药产品批发商300多家。shenzhou pefots 国 家 Country 中医/针灸师 人 数 TCM practitioners 中 医 药 学 校 TCM Schools 中医药学会 TCM associations 中医药产品供应商 TCM product suppliers 资料来源 Data source 全日制 Full-time 非全日制 Part-time 年毕业生人数
7、Year graduates 毕业要求平均学时 Study hours 奥地利 Austria 6500 1 9 150 140-500 6 10 W.Eichwer 保加利亚 Bulgaria 150 1 20 400-800 1 2 Z.Goranova 比利时 Belgium 900 4 80 1080 3 4 V.Herv 丹麦 Denmark 500 8 50 250-800 3 5 I.Holm 芬兰 Finland 130 2 30 100 2 3 祝国光 法国 France 7000 1 40 500 650-3250 6 15-20 F.Marguer 德国 Germany
8、50000 30 600 140-350 25 35 M.Wark 希腊 Greece 350 7 60 4 5 匈牙利 Hungary 300 4 70 3-5 2 爱尔兰 Ireland 600 2 50-60 1500 3 3 B.Ward 意大利 Italy 3000 15 250 600 25 5 C.M.Giovanardi 荷兰 Netherlands 4000 7 120 280-760 7 15 M.de Boer 拉脱维亚 Latvia 960 1 2 360 4800 4 N.Nickolaev 立陶宛 Lituania 200 1 300 1 1 N.Vitalijus
9、 挪威 Norway 1750 10 150-200 800 4 3 N.E.Volden 波兰 Poland 3000 1 5 100 3 10 A.Curzytek 葡萄牙 Portugal 2000 7 100-300 100-5000 5 4 P.Choi 西班牙 Spain 7700 1 4 80 1600-3000 4 2 R.M.Calduch 瑞士 Switzerland 1300 30 400 3 10 F.Urbahn 英国 UK 11350 6 11 310 80-3600 15 28 张鹏 合计 TOTAL 101690 11 194 3180 126 171 表1.欧
10、 洲 20 国 中 医 药 概 况 统 计 表 TCM situation in 20 European countries shenzhou pefots TCM products are available all over Europe and the demand is on the increase year by year.TCM provides remedies for many chronic and difficult medical conditions for which modern medicine has no satisfactory solutions.It
11、also helps to lessen the healthcare cost and generate employment.中药及其制品已遍布欧洲各国，而且需求量正在不断增加，这不仅增强了传统药物与化学药物的互补性，治愈了许多西方医药难以治疗的疑难病、慢性病，同時也减轻了欧洲各国沉重医疗费用的负担，并给社会创造了大量的就业机会。shenzhou pefots TCM is yet to be officially recognized in Europe.Like other complementary therapies,TCM has no official legal status
12、 in most European countries.Chinese traditional herbal products can only be imported and sold as foodstuffs or cosmetics.中医药尚未得到欧洲各国政府的足够重视，还无应有的法律地位。目前，中医药只能作为民间的一种替代疗法而生存和发展，中草药制品也只能作为食品、营养品或食品补充剂、化妆品等进入西方市场。shenzhou pefots Although acupuncture cost can be partly reimbursed from the public health
13、insurance in many European countries,the cost of herbal remedies can only be partly reimbursed from private insurance.Many people cannot afford to pay herbal cost and are unable to finish the full course of the treatment.虽然针灸费用能在大部分国家医疗保险公司报销，但中草药及其制品的费用仅在私人医疗保险能得到部分报销，其国民医疗保险仍由患者本人承担，因此导致一部分低收入的病员、
14、或患有慢性病的患者无法坚持而中途放弃治疗。shenzhou pefots The EU Traditional Herbal Medicine Products Directive came into force on 30 April 2004.The Directive allows traditional herbal medicinal products to be registered if they have been safely used in the EU for at least 30 years or 15 years in the EU plus 30 years el
15、sewhere.Products to be registered must also comply with the pharmaceutical quality standards.为了统一欧盟各国的传统药市场，欧盟传统药品法规定从2004年5月开始在欧盟国家境内使用了30年以上的传统草药制品，或者在欧盟使用 15年以上，同时在欧盟以外的国家和地区应用了 30年以上，符合药品质量标准的传统草药制品，可以在欧盟各国登记注册作为传统草药制品在欧盟销售和使用。shenzhou pefots The Directive aims to ensure the safety and quality o
16、f herbal medicinal products in Europe.It also provides legal framework for Chinese herbal products entering therapeutic drug market,opening a new possibility for TCM products entering the mainstream traditional medicines market in the EU.欧盟传统药品法对保障传统药品的质量和安全有着非常积极的作用，也为传统中药制品以治疗药品身份进入欧盟提供了法律依据，也为传统中
17、药制品进入欧盟主流药品市场的良好机遇。shenzhou pefots By 2009,more than 140 traditional registrations have been granted in the EU.However,no regiatration has been granted to TCM products because(1)No Chinese herbal manufacture has obtained EU GMP certification;(2)Difficulty collecting 15 year EU traditional use eviden
18、ce;(3)Complexity in composition and quality control;(4)Compliance problem of TCM indications with self-medication indications.截至2009年，已有140多个传统药产品在欧盟成员国获得传统药品注册。但至今还没有传统中药申请注册，主要原因是(1)中国还没有一家中药制药厂获得欧盟 GMP认证；(2)中药制品组成复杂、质量控制难度大；(3)中医传统适应症是否适合传统药品法要求等。shenzhou pefots Complex composition and traditiona
19、l TCM indications are not insurmountable problems because a product registered in Germany contains 13 ingredients,many of which,such as ginger,black peper,nutmeg,cardamom and cinnamom bark,are also used in TCM.According to some HMPC members,non European traditional indications may also be acceptable
20、.不过，这些问题不是不可以克服的。因为德国注册的传统药就是由13味药组成，其中不少成分如生姜、胡椒、肉豆蔻、高良姜、肉桂等也是常用中药。说明组成复杂这个问题是可以解决的。欧盟植物药委员会成员也明确表示传统医学适应症也是可以考虑接受的。shenzhou pefots EU Food Supplements Directive is another important legislation that will have major impact on TCM products in the EU.Currently,the Food Supplements Directive only gove
21、rns vitamins and minerals.除欧盟传统药品法外，欧盟食品补充剂法是又一个将对欧洲中药市场产生深远影响的重要法规。欧盟食品补充剂法目前只管辖维生素和矿物盐类。shenzhou pefots The European Food Safety Authority(EFSA)is collecting safety data on herbs and is to propose rules on herbs in accordance with the Food Supplements Directive.目前欧盟食品安全局正在收集有关草药的安全性资料，为按照食品补充剂法制定草
22、药制品的管理办法提供依据。shenzhou pefots In the foreseeable future,Chinese herbal products will enter the EU market as food supplements as they have been in the past.We hope that EFSA will take a practical approach in developing the Negative List so that those already on the EU market will be able to remain on
23、the market.中药作为食品补充剂进入欧盟市场为中药在欧洲的发展起到了积极的作用，在可预见的将来大部分中药制品将仍然以食品补充剂的身份进入欧盟市场，我们希望欧盟食品安全局根据欧盟草药市场实际情况，制定切合实际的草药制品管理办法，以保证现在已经在欧盟销售的中药能够继续销售。shenzhou pefots Furthermore,technical requirements such as heavy metal and pesticide residues and microbial limits also pose restrictions on Chinese herbs in Eur
24、ope.另外，高门槛的技术壁垒、绿色贸易壁垒给中药产品进入西方市场设置了巨大的障碍，各国政府不断地通过用药安全和环境保护等措施，加强对进口传统药品的规划管理，制订或提高相关的技术要求，如包括重金属含量、农残量、微生物限量等指标。shenzhou pefots There have been incidents where traders were not aware of the international agreement of the trade of endangered species and toxic plants that are forbidden in the EU mar
25、ket.还有些进口商、中医药专业人员对于濒危野生动植物受保护的种类和品种不了解，造成执法机关和媒体的误解。shenzhou pefots 中药名 药材拉丁名 原动物拉丁名 穿山甲 Squma Manis Manis pentadactyla 玳瑁 Carapax Eretmochelys Eretmochelys imbricata 鳄鱼 Crocodylia spp.龟板 Carapax et Plastrum Testudinis Chinemys reevesii 海马 Hippocampus Hippocampus spp.猴枣 Calculus Macacae Macaca mula
26、tta 虎骨 Os Tigris Panthera tigris 羚羊角 Cornu Antelopis Saiga tatarica 麝香 Moschus Moschus spp.犀牛角 Cornu Rhinocerotis Rhinoceros spp.象牙 Dens Elephantis Elephas spp.熊胆 Fel Ursi Ursidae spp.眼镜蛇 Naja spp.欧 盟 违 禁 动 物 类 中 药 Forbidden Chinese herbs from protected animals shenzhou pefots 中药名 药材拉丁名 原植物拉丁名 备 注 白
27、及 Rhizoma Bletillae Bletilla striata 沉香 Lignum Aquilariae Resinatum Aquilaria sinensis 狗脊 Rhizoma Cibotii Cibotium barometz 胡黄莲 Rhizoma Picrorhizae Picrorhiza kurrooa 中国药典品种Picrorhiza scrophulariiflora不受保护 芦荟 Aloe Aloe ferox 库拉索芦荟Aloe barbadensis不受保护 木香 Radix Aucklandis Aucklandia lappa 别名Saussurea
28、lappa,S.costus 人参 Radix Ginseng Panax ginseng 仅限于俄罗斯种群的根部 肉苁蓉 Herba Cistanches Cistanche deserticola 石槲 Herba Dendrobii Dendrobium cruentum 桃耳七（龟臼）Radix Podophylli Podophyllum emodi 别名Podophyllum hexandrum 天麻 Rhizoma Gastrodiae Gastrodia elata 西洋参 Radix Panacis Quinquefolii Panax quinquefolium 仅生药（根
29、和能辨认出是根的部分）受保护，其制品（冲剂、丸、片、茶、提取物等不受保护）欧 盟 违 禁 植 物 类 中 药 Forbidden Chinese herbs from protected plants shenzhou pefots 中药名 药材拉丁名 原植物拉丁名 草乌 Radix Aconiti Kusnezoffii Aconitum kusnezoffii 川乌 Radix Aconiti Aconitum carmichaeli 附子 Radix Aconiti Preparata Aconitum carmichaeli 关木通 Caulis Aristolochiae Mansh
30、uriensis Aristolochia manshuriensis 广防己 Radix Aristolochiae Fangchi Aristolochia fangchi 火麻仁 Fructus Cannabis Cannabis sativa 厚朴 Cortex Magnoliae Officinalis Magnolia officinalis 马兜铃 Fructus Aristolochiae Aristolochia contorta,Aristolochia debilis 麻黄 Herba Ephedrae Ephedra spp.马钱子 Semen Strychni Str
31、ychnos nux-vomica 青木香 Radix Aristolochiae Aristolochia debilis 细辛 Radix et Rhizoma Asari Asarum heterotropoides,A.sieboldii 天仙藤 Herba Aristolochiae Aristolochia debilis,Aristolochia contorta 洋金花 Flos Daturae Datura metel 罂粟壳 Pericarpium Papaveris Papaver somniferum 由于毒性等原因被禁的中药品种由于毒性等原因被禁的中药品种 Forbi
32、dden“toxic”Chinese herbs shenzhou pefots 重金属 Heavy metals 限量 Limits 铅 Pb 5.0 mg/kg 镉 Cd 0.2 mg/kg 汞 Hg 0.1 mg/kg 中草药、中成药重金属限量 Limits of heavy metals in herbs shenzhou pefots 霉菌毒素 Mycotoxins 限量 Limits 黄曲霉毒素 Aflotoxins B1 2.0 g/kg B1 B2 G1 G2 4.0 g/kg 赭曲霉毒素A Ochratoxin A 10.0 g/kg 中草药霉菌毒素限量 Mycotoxins
33、 limits in herbs shenzhou pefots Most EU member states do not allow irradiated foods on the market whereas many Chinese herbal manufacturers use irradiation to reduce microbial contamination.Chinese herbal manufacturers need to find non-irradiation methods for this purpose in order to export their p
34、roducts to the EU.绝大部分欧盟成员国不允许经过钴60或其它放射性同位素辐照灭菌的食品上市销售。有些中药材和中药制品是经过辐照灭菌消毒的，因此不可以在欧盟市场销售。为了保证中药进入欧盟市场，中国中药生产企业必须采用非放射性灭菌法消毒中药。shenzhou pefots TCM research is on the agenda of EU Research Framework Program.FP7 allocates special fund to set up a TCM research network in the EU.Chinese Ministry of Scie
35、nce&Technology,EU DG Research and Italian Ministry of Health jointly organized the Sino-European Conference on Traditional Chinese Medicine in Rome last year.值得指出的是，中医药研究已经引起欧盟的重视。在欧盟第7个框架研究计划中专门拨款支持中医药研究。中医药研究成为中欧科技合作的重要主题。中国科技部、欧盟科研总局和意大利卫生部还在去年共同组织专门在意大利罗马召开了由中欧各国政府有关部门和大学、研究机构参加的规模盛大的中欧中医药大会。she
36、nzhou pefots Quality standards for Chinese herbs in Europe are also on the agenda.British Pharmacopoeia has published monographs for Chinese herbs Dasngui,Huangqi,Baishao,Shenshen and Gancao.60 Chinese herb monographs are ready for publication in the French Pharmacopoeia.European Pharmacopoeia has p
37、roposed to prepare 84 Chinese herb monographs.欧洲中药质量标准的建立也已经提到议事日程，英国药典率先公布了当归、黄芪、白芍、人参、甘草等几个常用中药的药典标准。法国已经完成了60个常用中药的法国药典标准。欧洲药典正在准备84个中药的欧洲药典质量标准。这些药典标准完成后，将大大促进欧洲市场重要的质量控制。shenzhou pefots THMPD and FSD provide legal framework for Chinese herbal products to enter EU herbal medicinal products marke
38、t.Traditional registration will open a new market for Chinese herbal products in Europe where right now only a few member states allow CHM products market entry.欧盟传统药品法和食品补充剂法为中药产品进入欧盟主流传统药和保健品市场提供了法律依据。注册传统药品，将改变目前中药产品身份不明，改变目前中药制品只能直接进入少数几个欧盟成员国市场的不利局面，为中药产品开辟一个全新的市场。shenzhou pefots Quality and sa
39、fety are the basis for the further developement of Chinese herbal products in Europe,and must be an important part of the TCM internationalization strategy.Those wish to enter or expand in the EU must work hard to achieve the following:质量和安全是中医药在欧洲生存和发展的关键，必须成为中医药国际化战略的重要组成部分。为了使中医药真正进入欧洲主流医疗保健体系，扩大中医药国际市场，有志进入欧盟主流传统药和保健品市场的中药企业必须采取措施：shenzhou pefots?EU GMP compliance?Safety data of Chinese herbs?Evaluate efficacy of Chinese herbal products?Registration of safe and effective herbal products?欧盟GMP认证?收集整理常用中药的安全性资料?按照国际公认的临床研究标准评价中药的疗效?注册登记安全有效的中药制品 shenzhou pefots 谢 谢!Thank you!
