【摘要】：《歐盟傳統(tǒng)草藥法令》(2004/24/EC)的頒布與實(shí)施，一方面從法律角度承認(rèn)了傳統(tǒng)草藥的藥品地位，為我國中成藥通過傳統(tǒng)草藥簡(jiǎn)化注冊(cè)申請(qǐng)途徑加以注冊(cè)并以藥品的形式進(jìn)入歐盟市場(chǎng)提供了可能；但另一方面該法令設(shè)置的種種限制迫使我國中成藥2011年4月30日如還未成功注冊(cè)將不僅不能以目前保健品、食品添加劑等形式繼續(xù)銷售，而且還會(huì)被迫退出歐盟市場(chǎng)。如今，7年寬限期已經(jīng)到期，中國中草藥企業(yè)至今為止沒有一家通過歐盟注冊(cè)，歐盟作為中藥出口的中藥市場(chǎng)之一，如果我國中草藥企業(yè)的產(chǎn)品不能通過注冊(cè)上市將對(duì)我國中藥行業(yè)產(chǎn)生巨大的影響。 本文以《歐盟傳統(tǒng)草藥法令》(2004/24/EC)的正式實(shí)施為切入點(diǎn)，結(jié)合中草藥在國際注冊(cè)中所遇到的問題和所處的局面，通過對(duì)歐盟及其各國、美國、日本、澳大利亞和香港等其他國家和地區(qū)的中草藥和傳統(tǒng)植物藥注冊(cè)的相關(guān)法規(guī)與中國相應(yīng)的法規(guī)和政策進(jìn)行比較和分析，其中主要對(duì)各國中草藥注冊(cè)法規(guī)中關(guān)于申請(qǐng)類別、審批程序、申報(bào)資料等相關(guān)法條進(jìn)行對(duì)比分析，從而針對(duì)我國中草藥境外注冊(cè)過程中的難點(diǎn)針提出相應(yīng)的應(yīng)對(duì)策略略和法律建議；本文嘗試將國民待遇原則引入到中草藥傳統(tǒng)使用證據(jù)效力上，以使發(fā)達(dá)國家承認(rèn)而符合其使用年限的規(guī)定進(jìn)而獲得注冊(cè)；本文通過對(duì)歐美等國家和地區(qū)關(guān)于中草藥注冊(cè)的相關(guān)法律定性為中草藥國際貿(mào)易技術(shù)壁壘并對(duì)其進(jìn)行法律分析，結(jié)合相關(guān)的世界貿(mào)易規(guī)則對(duì)這一壁壘提供相應(yīng)的對(duì)策和法律解決方案。通過對(duì)各國家和地區(qū)中草藥注冊(cè)法規(guī)的比較和分析，給我國中草藥知識(shí)產(chǎn)權(quán)保護(hù)和注冊(cè)法規(guī)提供相應(yīng)的立法建議，，從而加速我國中草藥的國際化和現(xiàn)代化進(jìn)程。
[Abstract]:The promulgation and implementation of the European Union traditional Herbal Medicine Act (2004/24/EC), on the one hand, recognizes the drug status of traditional herbal medicine from the legal point of view, which provides the possibility for Chinese proprietary medicine to register through the simplified registration application of traditional herbal medicine and enter the EU market in the form of drugs; On the other hand, the restrictions imposed by the decree will force China's proprietary Chinese medicine to be not only unable to continue to sell in the form of current health products and food additives, but also forced to withdraw from the EU market if it is not successfully registered on April 30, 2011. Now, the seven-year grace period has expired, so far none of the Chinese herbal medicine enterprises have been registered through the European Union. As one of the traditional Chinese medicine markets exported by traditional Chinese medicine, if the products of Chinese herbal medicine enterprises can not be registered and listed, it will have a great impact on China's traditional Chinese medicine industry. Based on the formal implementation of the European Union traditional Herbal Medicine Act (2004/24/EC), combined with the problems encountered in the international registration of Chinese herbal medicine and the situation in which it is located, this paper compares and analyzes the relevant laws and regulations of Chinese herbal medicine and traditional plant medicine registration in other countries and regions, such as the European Union and its countries, the United States, Japan, Australia, Hong Kong and other countries and regions, and the corresponding laws and policies in China. Among them, the application categories, examination and approval procedures, declaration materials and other relevant laws and regulations in the registration laws and regulations of Chinese herbal medicine are compared and analyzed, and the corresponding countermeasures and legal suggestions are put forward in view of the difficulties in the process of overseas registration of Chinese herbal medicine. This paper attempts to introduce the principle of national treatment into the evidentiary effect of the traditional use of Chinese herbal medicine in order to make the developed countries recognize and conform to the provisions of their useful life and then obtain registration. In this paper, the relevant laws on the registration of Chinese herbal medicine in Europe and the United States and other countries and regions are characterized as technical barriers to international trade of Chinese herbal medicines and legal analysis, combined with the relevant world trade rules to provide corresponding countermeasures and legal solutions to this barrier. Through the comparison and analysis of the registration laws and regulations of Chinese herbal medicine in various countries and regions, this paper provides corresponding legislative suggestions for the protection and registration of intellectual property rights of Chinese herbal medicine, so as to accelerate the internationalization and modernization of Chinese herbal medicine.
【學(xué)位授予單位】：華南理工大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2012
【分類號(hào)】：D997.1;F203;R-051

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