2015 the five industry barriers of Chinese herbal medicine industry faces 
 
 
The 2015-01-07 12:02 0
 
 
Source: China Taiwan network 

    Business club in the January 7th
 
    Traditional Chinese medicine industry is an important part of the pharmaceutical industry, is also a strategic industry of our country, relationship between the national health and the development of the Chinese nation. Proprietary Chinese medicine industry in the industrial chain, the upstream industry mainly include Chinese traditional medicine planting industry and related production equipment industry to provide for traditional Chinese medicine industry, etc., such as medicinal herbs cultivation base, Chinese herbal medicine processing research and development base, etc. Downstream industries including medicine circulation, residents' health, and insurance industries, mainly Chinese medicine consumer market, there are hospitals, pharmacy, some supermarkets and shops. Their common industry chain of traditional Chinese medicine industry.
 
    Traditional Chinese medicine industry and domestic profitability strong industry, products with high profit margins. Within the pharmaceutical industry, traditional industry earnings level is higher. Proprietary Chinese medicine industry in China in 2012 sales income 407.916 billion yuan, up 20.73% from a year earlier. Total profit of 43.647 billion yuan, up 17.20%, the industry development situation is good. As of the end of June 2013, proprietary Chinese medicine production of 1.542 million tons, in China, though a year-on-year growth of 11.94%, but growth has dropped 13.07% from a year earlier.
 
    Since 2014, Chinese herbal medicine industry is the slowdown in the growth, raw material market also begin to enter the downturn, the market demand, in industry bottlenecks. 2014 has been in the past, we will resolve for you in the coming year 2015, Chinese herbal medicine industry will face barriers to which industries.
 
    First, policy barriers
 
    Because the drug is closely related to people's lives and health, so drug production by the government are more strict management. Implement a license system for pharmaceutical production enterprise in our country, the newly established drug manufacturing enterprise, must have certain conditions, must get the state pharmaceutical production license issued by the pharmaceutical supervisory and administrative department. In order to strengthen the quality management of pharmaceutical enterprises, guarantee the people's drug is safe and effective, the provisions of the state all drug preparations of production must conform to GMP requirements, which greatly improves the industry barriers to entry.
 
    Second, capital barriers
 
    The pharmaceutical industry is a high technology, high risk and high investment industry. In general, drug research and development, clinical trials and trial production to the sale of the final product, need to spend a lot of time resources, funds, personnel, equipment, etc. With the promulgation and implementation of the "the drugs management method" the development of proprietary Chinese medicine industry in our country is becoming more and more standardization and industrialization, and the quickening pace of modernization of proprietary Chinese medicine production, proprietary Chinese medicine enterprises in the aspects of technology, equipment and talent into bigger and bigger. Proprietary Chinese medicine industry has developed into a technology intensive, capital intensive and scale efficiency, without some sort of support and advanced management technology, capital, is not in the increasingly fierce market competition foothold, therefore, to enter the proprietary Chinese medicine industry enterprises have higher capital and size requirements.
 
    3, brand barriers
 
    Proprietary Chinese medicine curative effect is clear product positioning, brand and consumer loyalty is high, stable sales. Traditional consumer drug habit is stable, high loyalty of used products. New proprietary Chinese medicine enterprises want from the hand of the existing enterprise compete for customers, products, marketing and other aspects so as to have large-scale investment, and this kind of investment has a great deal of risks.
 
    Fourth, patent barriers
 
    The pharmaceutical production enterprise intellectual property protection in China. Enterprise research and development of new drugs, in addition to according to the measures for the administration of drug registration (sfda order 28), regulations on the protection of TCM variety (state council order no. 106), such as administrative protection, can also according to the patent law, the law on guarding state secrets shall enjoy the legal protection.
 
    On January 1, 1993, our country implements the regulations on the protection of TCM variety, provisions in the measures for new drug approval of new drugs after the expiry of the protection, can apply for protection of TCM variety. Level variety protection is 10 to 30 years Chinese medicine, Chinese medicine varieties of secondary protection for 7 years. TCM varieties under grade 1 protection after the expiry of the protection can apply for greater protection, extend the term of protection of the protection period shall not exceed the approved for the first time. After the expiry of the traditional Chinese medicine (TCM) secondary protection varieties protection could be extended by seven years. If the drug patent in China and has been approved, the drug will be made by the date in accordance with the provisions of the patent law to protect the application. During the period of protection, the state food and drug administration can't accept or other enterprise with varieties of traditional Chinese medicine (TCM) for examination and approval of application for registration.
 
    Five, the technical barriers
 
    Due to the drug production by the government is relatively strict management, the production technology level of related have higher requirements. For drug production licenses and GMP certificate, required for a long time, to the enterprise production technology level the demand is higher, general enterprise if it does not have sufficient technical preparation, difficult to obtain the corresponding qualifications.
 
    From the point of dosage form, injectable drugs due to directly enter the body, the security requirement is higher, the corresponding production technology is difficult.