Chinese herbal medicine certification management supervision blank

As we all know, the Chinese medicine industry involves a long chain. The upper reaches of the industrial chain include traditional Chinese medicine agriculture (medicinal planting and aquaculture), middleware processing industry and traditional Chinese medicine knowledge industry (formula), and downstream pharmaceutical marketing. Each chain and link can be divided into more sub-production industries, any of which A problem with a small sub-component may lead to the obstruction of the development of the entire Chinese medicine industry. Regardless of the extension of the TCM industry chain, there is always a source, especially for industries with high requirements for safety and validity. The quality of the source determines the scalability of the follow-up industrial chain and the development space of the entire industry.

Traditional Chinese medicine is the source of modernization of traditional Chinese medicine. The standardization of traditional Chinese medicine production is the basis for the modernization of traditional Chinese medicine, which directly affects the quality of traditional Chinese medicine products, relates to the advancement of modernization of traditional Chinese medicine, and relates to a series of issues such as whether internationalization of traditional Chinese medicine products can be achieved. To ensure the stability and homogeneity of Chinese herbal medicines, the only option is to implement GAP.

It can be said that there is no GMP for proprietary Chinese medicines without GAP in Chinese herbal medicines, there is no GLP and GCP for the development of new drugs, and of course, there is no GSP for drug administration. Therefore, to promote the modernization of traditional Chinese medicine, standardization and large-scale planting is the only way to achieve the modernization of traditional Chinese medicine.

“The current promotion of GAP is difficult and the progress is slow.” Professor Zhou Ronghan, chief scientist of GAP in China, told reporters that certified companies and bases have seen “recovery”.

At present, GAP has been officially launched for nearly 11 years. The country has certified only a total of more than 60 varieties, 113 companies and 61 Chinese herbal medicine production bases. There are about 360 species of Chinese herbal medicines that are commonly used in China—this means that at the current pace, it will take at least several decades to complete this work.

More than half of the companies have been unable to contact since the acceptance of GAP certification in 2003. By March 2013, the State Food and Drug Administration officially promulgated GAP inspection notices for Chinese herbal medicines No. 1 to No. 21. The announced enterprises and varieties have basically passed inspection and acceptance. In accordance with the requirements of the "Standards for Quality Management of Chinese Medicinal Materials (Trial)". As of mid-March 2013, 113 Chinese herbal medicine companies across the country have passed GAP certification for Chinese herbal medicines. It is worth noting that at present, companies have also accelerated the certification of GAP bases. From February 2012 to February 2013, within only one year, 23 companies have passed GAP certification, accounting for 20.35 of all GAP bases. %.

Although the importance of GAP certification for Chinese herbal medicines has been widely recognized both inside and outside the industry, the reporter found that the development status of some companies or bases that have already achieved certification is not satisfactory. The reporter found in a recent research report on the “Development Status of China's Accredited GAP Bases” by Dr. Jiang Chengzhao, Deputy Director and Deputy Researcher of the GAP Working Committee of the Chinese Pharmaceutical Quality Association. Dr. Jiang Chengzhao and his team passed the GAP certification. A total of 113 companies answered the phone and found that most of the company's GAP base phones were in a state of no answer, and even worse, the phone had arrears and downtime. Among them were Beijing Tongrentang, Nanyang Zhang Zhongjing, Shaanxi Tianshili, and other well-known Chinese medicine production. enterprise.

After several months of hard work, after one-on-one telephone interviews with 113 Chinese certified companies, Dr. Jiang Chengzhao found that 47 companies had empty or wrong phone numbers, which accounted for 42.23% of the total. There were 28 unanswered calls. Homes accounted for 24.56% of the total; there were 6 outages, which accounted for 5.26% of the total; and there were only 29 enterprises with good GAP operations, accounting for 25.44% of the total. For example, Beijing Tongrentang’s production bases such as Hawthorn, Banlangen, and Bittering have not been answered by telephones for long periods of time, and Shaanxi’s Tasly’s Salvia base phone has already become a space number.

In response to this situation, a production base operator who asked not to be named stated that because the attitude of the competent authorities for GAP certification is not as resolute as GMP certification, they have not paid enough attention to the supervision of certified companies, resulting in the cost of this one. Many of the hugely-built GAP bases are more like "image projects" used by Chinese medicine companies. They sound good and look good, but they do not have much substantive effect.

The experts from the government-enterprise joint venture promote development pointed out that the development of GAP bases for Chinese herbal medicines should fully understand and understand the connotations of GAP, understand the conditions and essentials for the standardized production of Chinese herbal medicines, combine the actual conditions, clearly implement the main body, and strengthen the whole process of monitoring. Continuously improve the coordination mechanism, and constantly explore and innovate to ensure the effective operation of the Chinese herbal medicine GAP base and achieve good economic, social and ecological benefits.

In the process of implementing GAP management, science and technology support and take the road of science and technology. On the one hand, we must consider the suitability of the ecological environment, respect the law of the growth of authentic herbs, avoid blindly introducing species, and unilaterally pursue large-scale production; on the other hand, we should encourage localities to take full advantage of their advantages in producing deep-processing and serialized development and production of single varieties. Single species scale, modern development. We will further enhance the quality and quality of authentic medicinal herbs, create brands, participate in international market competition, and finally form a good situation in which various varieties will advance together and the level of modernization of the traditional Chinese medicine industry will improve overall.

Improve collaboration mechanisms. At present, many bases implement the operating model of company + base + farmer, organically combining the interests chain of planting, processing, and sales, which not only ensures the quality of medicinal materials, but also guarantees the sales of medicinal materials. At this time, it is necessary to establish a good collaboration mechanism, and enterprises should take the lead to establish a GAP planting demonstration base in the major producing areas of medicinal materials in order to promote the promotion and application of GAP planting technology among farmers, adopt unified planting contracts, unify and standardize management, and acquire foreign sales. The method provides free seedlings and techniques for growers, organizes standardized plant management and market sales, and avoids the problem of quality and sales of medicinal materials caused by sporadic planting of farmers. At the same time, local governments at all levels should increase their support for GAP bases in terms of policies, funds, etc., focus on communicating and coordinating with farmers, and achieve long-term, mutually beneficial, and win-win goals for both companies and farmers.

In addition, the State Food and Drug Administration and the State Administration of Traditional Chinese Medicine are called upon to revise and increase the specifications of the original Chinese herbal medicines. It is stipulated that the raw materials must be high-grade medicinal herbs or at least mixed medicinal herbs in order to improve the quality of finished medicines so as to facilitate implementation. Higher prices for quality and scientific management encourage pharmaceutical companies and pharmaceutical businesses to use high quality Chinese herbal medicines approved by GAP. It is recommended that the State institute a project on the technical standards for the cultivation of Chinese herbal medicines, which shall be led by the national or provincial food and drug administration. The GAP-certified enterprises shall bear the specific commitments and formulate the national standards for commonly used, bulk, and export medicinal herb cultivation techniques for the implementation of Chinese medicinal materials. Standardize production and lay a good foundation for the modernization of traditional Chinese medicine.