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The Comparative Study on Chinese Herbal Medicine Registration Laws

Author: ZhaoSai
Tutor: ZhouZuoWen
School: South China University of Technology
Course: Legal
Keywords: Chinese Herbal Medicine Registration Comparative Study Strategies
CLC: D997.1
Type: Master's thesis
Year: 2012
Downloads: 188
Quote: 0
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Abstract


The promulgation and implementation of"The EU traditional herbal Act"hasworked intwo facts.On the one hand,admitting the status of traditional herbal medicines from the legalpoint of recognition.The Act made it possible for Traditional Chinese medicinal productsthrough the simplified registration of traditional herbal medicines to be registered asmedicines to enter the EU market.On the other hand,the Act will not allow the TraditionalChinese medicinal products to sale as any style,like health care products or food additive,andwill force us to exit of the market if it is not succeed in registration until April30,2011.Today,the seven-years grace period has expired, but any of the Chinese herbal medicine companieshasn’t registered by the EU.The EU markets as a important Chinese exports market ofChinese medicine,so if Chinese herbal medicine company’s products can not be registered bythe EU,the China’s medicine industry will be faced with huge impact.In this paper, the formal implementation of the "EU traditional herbal Act(2004/24/EC)as the starting point，combined with the problems of the Chinese herbal medicine intheinternational registration.Compared the herbal registration laws of China and EU, theUnited States, Japan, Australia and Hong Kong and other countrys, then comparative andanalysis the odiances of the type of applyments,approval procedures and disclosureinformation.By the study of Chinese herbal medicines in the international registration,thensupply some legal advice and strategy for Chinese herbal medicine the InternationalRegistration. This paper attempts to reference the national treatment principle,then improvethe effectiveness of evidence of the Chinese herbal medicine’s traditional use. So thedeveloped countries will acknowledge the useful life of Chinese herbal medicine,then it canbe registrated in these countrys. In this paper,I think the herbal medicine registration laws is atype of Technical Barriers to Trade，and I will analysis it with law.By combined with worldtrade rules,I will provide some counter measures and legal solutions. In order to provide someadvice and guidances for Chinese herbal medicine registrated laws, and enhance the level ofIP laws protced for Chinese herbal medicine. I will refrence the case that the tea leaves extractcatechins listing of cases registered in the United States,then accelerate the progress ofinternationalize and modernize of Chinese herbal medicine.

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CLC: > Political, legal > Legal > International law > Private international law > International Civil
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