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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 diseas
3、es and well-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
4、表,现出它的独特作用和巨大潜力。,shenzhou 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
5、家和地区的卫生部签署了谅,解备忘录。,shenzhou 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,pr
6、oducts distributors all 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 so
7、urce,全日制,Full-time,非全日制,Part-time,年毕业生人数,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,7000,1,40,5
8、00,650-3250,6,15-20,F.Marguer,德国,Germany,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.Nickol
9、aev,立陶宛,Lituania,200,1,300,1,1,N.Vitalijus,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
10、鹏,合计,TOTAL,101690,11,194,3180,126,171,表,1.,欧,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 mode
11、rn,medicine has no satisfactory solutions.It 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 compl
12、ementary therapies,TCM,has no official legal status 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 acupunct
13、ure cost can be partly,reimbursed from the public health 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
14、，,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、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
15、,EU,for,at,least,30,years,or,15,years,in,the,EU,plus,30,years,elsewhere.,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
16、在欧,盟销售和使用。,shenzhou pefots,The,Directive,aims,to,ensure,the,safety,and,quality,of,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 medicine
17、s 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 o
18、btained EU GMP certification;(2)Difficulty,collecting 15 year EU traditional use evidence;(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,
19、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 traditional 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
20、 used in TCM.According to,some HMPC members,non European traditional,indications may also be acceptable.,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 legi
21、slation that will have major impact on,TCM products in the EU.Currently,the Food,Supplements Directive only governs 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 an
22、d 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 ta
23、ke a,practical approach in developing the Negative List so,that those already on the EU market will be able to,remain on 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,techn
24、ical requirements such,as heavy metal and pesticide residues and,microbial limits also pose restrictions on,Chinese herbs in Europe.,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,tra
25、ders were not aware of the international,agreement of the trade of endangered,species and toxic plants that are forbidden,in the EU market.,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 imb
26、ricata,鳄鱼,Crocodylia,spp.,龟板,Carapax et Plastrum,Testudinis,Chinemys reevesii,海马,Hippocampus,Hippocampus,spp.,猴枣,Calculus Macacae,Macaca mulatta,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,s
27、pp.,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,白及,Rhizoma Bletillae,Bletilla striata,沉香,Lignum Aquilariae,Resinatum,Aquilaria sinensis,狗脊,Rhizoma Cibotii,Cibotium barometz,胡黄莲,Rhizoma Picrorhizae,Picror
28、hiza 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 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）,
29、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
30、Aconiti Kusnezoffii,Aconitum kusnezoffii,川乌,Radix Aconiti,Aconitum carmichaeli,附子,Radix Aconiti Preparata,Aconitum carmichaeli,关木通,Caulis Aristolochiae Manshuriensis,Aristolochia manshuriensis,广防己,Radix Aristolochiae Fangchi,Aristolochia fangchi,火麻仁,Fructus Cannabis,Cannabis sativa,厚朴,Cortex Magnoli
31、ae Officinalis,Magnolia officinalis,马兜铃,Fructus Aristolochiae,Aristolochia contorta,Aristolochia debilis,麻黄,Herba Ephedrae,Ephedra,spp.,马钱子,Semen Strychni,Strychnos nux-vomica,青木香,Radix Aristolochiae,Aristolochia debilis,细辛,Radix et Rhizoma Asari,Asarum heterotropoides,A.sieboldii,天仙藤,Herba Aristolo
32、chiae,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,Forbidden“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 herb
33、s,shenzhou pefots,霉菌毒素,Mycotoxins,限量,Limits,黄曲霉毒素,Aflotoxins,B,1,2.0,g/kg,B,1,B,2,G,1,G,2,4.0,g/kg,赭曲霉毒素,A Ochratoxin A,10.0,g/kg,中草药霉菌毒素限量,Mycotoxins limits in herbs,shenzhou pefots,Most EU member states do not allow irradiated,foods on the market whereas many Chinese herbal,manufacturers use irrad
34、iation to reduce microbial,contamination.Chinese herbal manufacturers need to,find non-irradiation methods for this purpose in order to,export their products 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
35、,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,Science&Technology,EU DG Research and Italian,Ministry of Health jointly organized the Sino-European,Conference on Traditional Chinese Medicine in
36、 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。,shenzhou pefots,Quality standards for Chinese herbs in Europe are,also on the agenda.British Pharmacopoeia has published,monographs for
37、Chinese herbs Dasngui,Huangqi,Baishao,Shenshen and Gancao.60 Chinese herb,monographs are ready for publication in the French,Pharmacopoeia.European Pharmacopoeia has proposed,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
38、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 market.Traditional registration,will open a new market for Chinese herbal products,in Europe where right now only a few member,s
39、tates 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 safety are the basis for the further,developement of Chinese herbal products in Europe,and,must be an important part of
40、 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!,
