In 2003, China issued “Chinese Herbal Pieces, medical gases GMP Supplementary Regulations”, and 19 provinces (municipalities), 46 Chinese Herbal Pieces manufacturing enterprises certified checks, 2004, China released the “Pieces of Chinese medicine to promote the implementation of such categories as drug supervision GMP work notice “clearly required since January 1, 2008, all Chinese Herbal Pieces manufacturers must meet GMP under the conditions of production.
Research Center of Information Industry show that in recent years, China actively promote the Chinese medicine industry, GMP certification, and encourage mergers and reorganizations of Chinese medicine enterprises, such as the GMP standard, respectively, within the pharmaceutical industry, to promote the implementation of the overall quality of pharmaceutical companies and the industry to significantly improve, through restructuring in recent years, China has greatly reduced the number of traditional Chinese medicine companies, the industry has also created a group with certain competitive businesses.
GMP certification in China under the current situation of Chinese medicine
Pharmaceutical industry analysts pointed out that after the adjustment and development in recent years, Chinese medicine industry has gradually begun to take shape a new pattern, clearly showing a degree of industrial concentration continue to increase trend. Large-scale, modern enterprises use a high degree of brands, capital, technology, and policy advantages, pay close attention to mergers, restructuring and transformation of other enterprises, so that the accelerating pace of development of enterprises.
2009 is a global financial crisis further exacerbated the impact on the Chinese medicine trade a year, due to my lack of Chinese medicine products abroad, the approval and certification, and Chinese medicine products in foreign countries many of which are only used for dietary supplements, food, food additives and other areas, In addition, China’s self-realization of GMP-certified drugs are not too many, it had an impact on Chinese medicine international consumption, may make Chinese medicine trade into the “winter period.”
Followed by a GMP certified pharmaceutical companies transform or project after the investment boom, accompanied by chinese herbal Pieces GMP certified plant transformation or re-investment into the wind, clouds moving again, this is a traditional Chinese medicine development in the history of a momentous event. As the Chinese Herbal Pieces processing GMP certified amount of investment, compared with the pharmaceutical companies is not large, and thus attracted many foreign investors in the industry wide attention.
GMP certification hinder development of the industry of Chinese medicine Pieces
The pharmaceutical industry analysts pointed out that Chinese Herbal Pieces of the quality assurance policy environment being developed, each company to pass the GMP authentication Road “hard threshold” the rectification of approximately 10 million yuan investment, which in a certain level, the size and strength so that those who retain large enterprises, industry concentration will be further enhanced. However, the expectation alone GMP certification on the quality of Chinese medicines Pieces overall increase is unrealistic, but also a series of supporting policies and regulations, as well as healthy competition in the market to progressive realization.
First of all, Chinese Herbal Pieces lack of national standards for quality management. GMP for the production of conditions to protect, regulate the production has been clearly defined, which can only be considered a first step in the quality of standard Pieces. In the 2005 edition of “The People’s Republic of China Pharmacopoeia” and middle-income by approximately more than 500 kinds of Chinese medicinal herbs for, this is the quality of raw materials for Chinese Herbal Pieces major judgments based on national-level Chinese Herbal Pieces need to further improve the overall quality standards.
Second, the standardization of Chinese Herbal Pieces cooked up processes and confidentiality that exists between a certain contradiction. China from the 20th century, 50 years technology will be fabricated to include security technology areas, followed by a number of government laws and regulations expressly prohibit bulk exports of toxic Chinese medicines and Chinese medicine processing technology and processing technology of producing the same time, to prohibit foreign investment in Chinese Herbal Pieces of traditional processing technology areas, ban on technology is also rumored to Chinese Herbal Pieces cooked up the standardization process and the confidentiality of the contradiction between the long-standing.
National GMP certification industry to promote the healthy development of Chinese Herbal Pieces
Chinese Herbal Pieces problems directly affect the future of the entire Chinese medicine industry, the survival and development. To solve the above problems, GMP transformation of paramount importance. This will present Chinese Herbal Pieces of China’s large-scale production structure adjustment, eliminating a large proportion of enterprises, especially the number of “cottage-style” small businesses, these enterprises will be formed out of a huge market space, the industry will be Chinese Herbal Pieces there will be a re-shuffle of the situation, high-quality leading enterprises in the process, on the one hand can be quickly occupied out of business and increase market share; the other hand, can also be opened up on the various forms of capital investment in upstream and downstream industry chain .
Pharmaceutical industry analysts pointed out that in this case, the State determined to pay close attention to drug production supervision and management, “National rectifying and standardizing the market order drugs special operations” are also in full swing. In 2006, the State Food and Drug Administration to convene in Beijing to rectify and standardize the national work conference on the pharmaceutical market in order to mobilize and deploy throughout the country to rectify and standardize market order pharmaceutical special action, and called for food and drug regulatory systems to earnestly implement the important Premier Wen Jiabao instructions and the State Council, and improve and regulate drug market order.
Initiatives to make most of the country’s harsh medicine Pieces of small enterprises to give up the attempt to muddle through, or hopes to extend the certification time, the dream of the country, have quit the industry for outstanding development of enterprises has provided a broad market space. In addition, through GMP-certified companies in the industry consolidation and the process of change has begun to enjoy the benefits of normalization and standardization, in addition to the above-mentioned increase in the market space, the Chinese Herbal Pieces of quality and standards are in the progressive development and norms, which helped a number of excellent enterprises, foreign market development.
Chinese Herbal Pieces industry GMP trends
Pharmaceutical industry analysts pointed out that with the implementation of GMP, etc., the standardization of Chinese medicine industry is higher than in the past have been greatly improved, the industry’s “multi-, small, scattered, chaotic” situation has improved significantly. Can be predicted that in the future development of the industry will become more standardized, including the planting Chinese herbal medicine, Chinese medicine Pieces processing, traditional Chinese medicine business and other links.
In addition, the standardization of development will permeate to all aspects of Chinese medicine industry, including: the industrialization of agriculture, medicine management and standardized production. This is the basis of traditional Chinese medicine industry for the entire industry with raw materials and physical infrastructure. Chinese Herbal Pieces concocted the standardization and quality standards for standardized, proprietary Chinese industrial production standardization. The standardization of traditional Chinese medicine business and so on.