The Study On The Registration Of Traditional Chinese Medicinal Products In The European Union

At present, the EU has expanded to involve 27 countries, with the total population of over 500 million. And it is larger than the North American Free Trade Agreement area becoming the largest trade zone in the world. This year, with the concept of "back to nature" is popular in the EU, the herbal market is rapidly expanded and the proportion of the market share is increased year by year. The promulgation and implementation of "The EU traditional herbal Act" has worked in two facts. On the one hand, admitting the status of traditional herbal medicines from the legal point of recognition. The Act made it possible for Traditional Chinese medicinal products through the simplified registration of traditional herbal medicines to be registered as medicines to enter the EU market. On the other hand, the Act will not allow the Traditional Chinese medicinal products to sale as any style, like health care products or food additive, and will force us to exit of the market if it is not succeed in registration until April 30, 2011. Based on proprietary status and future trends in the EU, this issue is necessary to introduce registration of Traditional Chinese medicinal products in the European Union. However, the registration is not easy as we thought, there are many difficulties as the restrictions of applications for simplifying registration, technical standards and certification system, the claims data of EU registration, and other technical barriers to trade. The barriers of external and internal environmental factors are both problems. We must solve these problems as soon as possible to change the status quo and the future fate of the EU's proprietary and to breakthrough the EU registration.This paper is based on the opportunities and challenges of the implementation of "EU traditional herbal Act" , analyzing the current EU market and the conditions of Chinese herbal products in the EU market, studying the management policies of the EU herbal medicine, analyzing the registration process category, the approval process , application data and other aspects of information of EU, carrying out the feasibility research of registration of Traditional Chinese medicinal products in the European Union. Aiming to fide the difficulties in the EU registration and putting forward countermeasures, in order to provide the strategic reference for the registration in the EU.