[straight news network Beijing April 8 hearing] (China industry news) "the internationalization process is not only the implementation of international varieties of traditional Chinese medicines, but need to involve pharmaceutical the industrial chain and accessories, packaging materials, equipment, software, instrumentation, solvent and the reference material related industries to fully implement the international, to create the internationalization of traditional Chinese medicine industry." This is the National People's Congress, Tasly Group Holdings chairman of the board of directors of Xijun submitted eleven bill in the National People's Congress.

Low level competition hinder industry internationalization

For a long time, our country pay attention to of upstream and downstream industry chain of traditional Chinese medicine technology to enhance the supervision and management, such as GaCp management, a new version of the GMP certification, but on Chinese medicine pharmaceutical supporting industries do not pay enough attention, resulting in exploring the road of internationalization of Chinese Medicine pioneer enterprises had to industry chain is longer, not only to complete the whole process of enterprise internationalization varieties international technical standards research and improve the system, also undertake the internationalization level of the species involved related industry promotion. However, some do not pay attention to varieties of traditional Chinese medicines overall technical level to improve quality of enterprise, through the use of low quality materials, package materials, equipment and other products in order to reduce the cost, is often in the low bid market environment to take the initiative. In this way, efforts to improve the level of product internationalization of enterprises, although the product quality is good, but bear the burden of unnecessary, and in the current domestic market competition in a cost disadvantage.

Yan Xijun think that caused this situation the reason is that our country of Chinese pharmaceutical equipment industry is still a lack of systematic norms and strict supervision, on the one hand to low quality materials market space, on the other hand also pulled down the entire Chinese medicine pharmaceutical level, was not recognized international, for Chinese enterprises in order to reduce the registration and certification risk, had to choose imported materials, imported equipment, international certification of software. This situation, if sustained, it will be difficult to effectively support more Chinese enterprises, more varieties of traditional Chinese medicines with the implementation of the international, even part of traditional Chinese medicine varieties to achieve the international registration, it is difficult to effectively stimulate the development of the overall Chinese manufacturing and supporting industries, it is difficult to support the internationalization of traditional Chinese medicine industry.

Three proposals to foster international competitiveness

In order to better implement the national development planning requirements of the Chinese medicine industry, promote the internationalization of traditional Chinese medicine industry, Yan Xijun recommendations:

First, led by the State Administration of traditional Chinese medicine, pharmaceutical related industry chain in charge of the industry sector coordination, set up a special inter ministerial joint working group, medicine, agriculture, chemical industry and other industries linkage, to the internationalization of traditional Chinese medicine for the common goal, clear pharmaceutical and supporting industry chain management responsibilities and specification requirements, promote domestic excipients, packaging materials, equipment, software, and gradually reached the international technical norms and standards, enhance the level of the overall security of the internationalization of traditional Chinese medicine. At the same time, traditional Chinese medicine pharmaceutical enterprises focus on the implementation of traditional Chinese medicine industry chain management and promotion, the formation of industry chain management and enterprise industry chain management division of labor clear, clear responsibilities, mutual coordination, collaborative development.

The second, led by the State Food and drug administration, the Ministry of Commerce and other ministries to support, established Chinese medicine international standard research and mutual recognition of the work of the group. Specific recommendations are:

Is the formation of China's traditional Chinese medicine research and development, evaluation, supervision and other technical specifications and systems, compared with the international plant medicine management, more systematic and comprehensive. Working group on the basis of reference FDA drug review mechanism to optimize the work flow, carding, establish and gradually promote a set of suitable for traditional Chinese medicine products R & D internationalization technical guidelines, approval standards and regulatory norms, change the internationalization of traditional Chinese medicines at present, the main chemical medicine with technology standard prevail with reference to the present situation, for the internationalization of Chinese medicine to provide guidance. For example: with the Pharmacopoeia Committee and other departments coordinated ICH members of China Pharmacopoeia and Chinese Pharmacopoeia reunification of Chinese herbal medicine, Chinese medicine extraction with solvent, commonly used pharmaceutical excipients quality standards; and Inspection Institute jointly promote the mutual recognition of China Chinese standard substance and USP, EDQM; traditional Chinese medicine CTD technical document specification publication and and and ICH coordination recognized set TCM cGMP norms as ICHGMP file appendix.

Second for traditional Chinese medicine industry of form a complete set, should absorb the international advanced management methods, vigorously promote the matched its industry characteristics and risks of the technology, production and quality management standard construction, and implement the strict management of the departments in charge of the industry, to enhance the overall level of the pharmaceutical industry of form a complete set. For example: the implementation of the pharmaceutical accessories, pharmaceutical packaging materials, such as the DMF system, the implementation of pharmaceutical equipment, software systems certification system, etc..

Three is for the enterprises of our country have been in the ICH members registered varieties of traditional Chinese medicines, "go back to" specialized simplify examination and approval procedures established to promote domestic industrialization in the internationalization of traditional Chinese medicines, for the benefit of the people of our country, and to encourage and guide the internationalization of traditional Chinese medicine varieties in the parallel development of, in order to continue to promote the process of internationalization of the series of varieties of traditional Chinese medicines.

Third, it is recommended the State Planning Commission lead, continue to improve the varieties of traditional Chinese medicines of the domestic market, high quality with low price etc. method, guide and encourage Chinese enterprises as a whole to enhance the level of product quality, avoid regardless of the quality of blindly reduce the cost approach, cultivate a group of high quality varieties of traditional Chinese medicine internationalization, gradually improve the international competitiveness of the whole Chinese medicine industry, to create the internationalization of traditional Chinese medicine industry. 3

(original title: Yan Xijun: perfect industry chain management to build the internationalization of Chinese medicine industry)

Editor: Chen Feng

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