Progress in registration of traditional botanical drugs in EU Member States

Source: China Medical Insurance chamber of Commerce 2015-07-16 EU is one of the most developed regions in the global economy, and also one of the regions with the longest history of traditional medicine use, as well as the main destination of traditional Chinese medicine export in China On March 31, 2004, the European Parliament and the Council issued the directive on the registration of traditional botanical drugs (2004 / 24 / EC), which revised the regulations on the registration of traditional botanical drugs in the directive on human drugs (2001 / 83 / EC), requiring that all traditional botanical drugs must be registered on April 30, 2011 The company shall obtain the marketing license through the registration procedure before, otherwise it shall not be sold in the name of drugs Recently, the European Medicines Agency released a collection of registration information of traditional botanical drugs in its member countries A total of 1319 traditional botanical drugs have been approved for marketing in member countries, of which 820 are single preparations, accounting for 62.2% of the total, 499 are compound preparations, accounting for 37.8% of the total [1] The author has combed the registration of traditional botanical drugs in EU Member States before June 30, 2011 [2] In the past two and a half years, 692 new marketing licenses have been added, including 388 new marketing licenses for unilateral preparations, 304 for compound preparations, and the number of registration for compound preparations has increased year by year Since the implementation of Directive 2004 / 24 / EC in EU Member States, EU member states have gradually implemented the registration and management of traditional botanical drugs Germany took the lead in approving the first registration application in 2005 As of December 31, 2013, 2327 applications had been accepted by EU Member States, of which 1319 were approved, 680 were in the evaluation stage, 168 were rejected by the competent authorities, and 160 were voluntarily withdrawn by the applicants In terms of annual approval quantity, from 2004 to 2008, 56 varieties were approved in five years for enterprises to be familiar with and prepare for the period Affected by the expiration of 7-year transition period, the approved quantity in 2011 was blowout, 253 varieties were approved in the first half of the year, 376 varieties were approved in the whole year, and the number of listed products in the next two years was 269 and 29 respectively EU is the main market of traditional Chinese medicine export in China Compared with other countries, its relevant policy and regulatory environment is also more favorable for Chinese patent medicine enterprises Therefore, it is necessary to increase the research on EU traditional plant medicine marketing license, so as to realize the marketing of bulk Chinese patent medicine products in EU Member States At the national level, GMP in PIC / s member countries can be achieved by promoting national GMP management system to join PIC / s organization In order to reduce the application cost and time, we need to further strengthen the exchange and cooperation with the same industry organizations in the EU, promote the technical cooperation between Chinese and European enterprises, and then realize the marketing of Chinese patent medicines through technology transfer and authorization At the enterprise level, we still need to further strengthen the basic research on traditional Chinese medicine, and establish quality standards that meet the international requirements At the same time, we actively participated in the evaluation and drafting of the European Herbal monograph, striving for more monographs to be included in the European Herbal monograph system or included in the European pharmacopoeia standard.