The business club reported on April 8th that the quality and specification of Chinese herbal medicine production once again aroused the attention of all parties. A reporter from the “Pharmaceutical Economics News†found that seminars related to the quality and specification of Chinese herbal medicines were frequently held in the near future.
Obviously, despite the fact that there is no clear plan for the promotion of the “Regulations for the Quality Management of Chinese Medicinal Plants (Trial)†(hereinafter referred to as the “Chinese Medicinal Materials GAPâ€) as mandatory certification like GMP, the government actively urges and fully promotes the industry and academia. Next, this industry norm is expected to usher in another rise. This also confirms that previous officials from the Ministry of Health stated that the government was prepared to increase the promotion of GAP certification for Chinese herbal medicines to ensure the sustainable development of herbal medicine resources.
Industry support
Regarding the latest progress in GAP certification, the reporter learned from the National Food and Drug Certification Review Center (hereinafter referred to as “the Centerâ€) that is currently responsible for carrying out GAP certification for Chinese herbal medicines. Sun Jinglin, director of the Central Inspection Division II, told reporters that experts from the center will inspect the certification of GAP certification for Chinese herbal medicines, and will be notified through the official website of SFDA for publicity.
Sun Jinglin said that at present, there is no assumption that the Chinese herbal medicine GAP certification as a compulsory certification.
The reporter then called Sichuan Good Doctor Pharmaceutical Group. The SFDA's latest issue of the first edition of the Chinese Medicinal Materials GAP certification announced that the company's subsidiary company's aconite production base has been certified as a Chinese herbal medicine GAP. Shen Yumei, vice president of Haoyao Pharmaceutical Group, said that although the cost of doing business according to GAP requirements will increase the cost of the company, the company’s confidence in the quality of its own products has also increased, and it has truly implemented the first link of quality of Chinese medicine in the land. The concept is more assured in terms of product quality stability and homogeneity.
In addition, Shen Yongmei also told reporters that Chinese medicines that use GAP-certified Chinese herbal medicines in domestic drug procurement can obtain certain points in some provinces. This allows companies to participate more actively in GAP certification of Chinese herbal medicines. Moreover, at present, there is also some understanding of the Chinese medicines GAP certification, which also increases the confidence in the export of products.
With the development of traditional Chinese medicine and the market demand for Chinese herbal medicines, the resources of herbal medicines have been seriously depleted, and the growth environment of Chinese herbal medicines resources has been destroyed. The resources of wild herbs have been continuously reduced, which has led to an increasingly prominent contradiction between the supply and demand of Chinese herbal medicines. The situation is very serious. In an interview, the reporter learned that Chinese herbal medicines should be planted and produced in accordance with the conditions of Chinese herbal medicine GAP specifications. The industry generally supports this.
The authoritative experts in GAP certification management of Chinese herbal medicines and the president of the Chinese Medicinal Organism GAP Research Promotion Association, Professor Zhou Ronghan, recently traveled frequently to Beijing to participate in technical seminars related to Chinese herbal medicines. Zhou Ronghan told reporters that at present, the Chinese herbal medicine industry is actively preparing to convene a commemorative conference to implement the 10th anniversary of China's implementation of GAP certification in 2012. It is reported that a number of domestic mainstream Chinese medicine companies have participated in the preparations for the conference.
Have twisted expectations and rejuvenation
The development of Chinese herbal medicine GAP during these years has not been easy.
In 2004, the first batch of 20 companies passed the GAP certification of Chinese herbal medicines. Among them, Tasly, Tong Ren Tang, and Te'an, etc. received certification for Salvia miltiorrhiza, ginseng and Panax notoginseng; in 2005, 8 companies passed certification; in 2006, there were 20 The home business is certified. In 3 years, 48 ​​companies passed the GAP certification of Chinese medicinal materials. At the 2006 World Health Organization's annual "Regional Collaborative Collaboration on Plant Medicines," GAP became the subject of intense debate.
However, only two companies and four companies passed certification in 2007 and 2008 respectively. This aspect was allegedly related to academic disputes at the time of GAP certification, and it was also suspected of coincidence with the “GAP†certification promoted by the CNCA.
In January 2006, the National Certification and Accreditation Administration formulated the “Guidelines for Good Agricultural Practice (GAP) Certification Implementation (Trial)â€. In August 2007, the CNCA amended the Good Agricultural Practice (GAP) and implemented it on January 1, 2008. The 561 companies in 25 provinces have already conducted pilot demonstrations of good agricultural practices certification. Currently, there are 410 certificates issued.
Up to now, only 75 companies have published GAP certifications for Chinese herbal medicines.
For the development and status quo of GAP certification of Chinese herbal medicines, Qin Mingjian, a professor of traditional Chinese medicine resources at the China Pharmaceutical University who has been paying attention to GAP certification for many years, told reporters that this is related to the difficulty and complexity of the GAP certification of Chinese herbal medicines. The majority of herbal medicine breeders are farmers, which are difficult to regulate and sensitive to interests. In addition, the investment involved in GAP certification of Chinese herbal medicines involves a relatively large amount of investment. The government has invested limited manpower and financial resources in pharmaceutical supervision. Therefore, relying on the government to promote Chinese herbal medicines GAP is not realistic at present. However, in the long run, with the development of the industry, it is an inevitable trend to implement a unified Chinese herbal medicine production specification.
Qin Mingjian further pointed out that at present, several countries and regions with rapid development of traditional drugs in the world, such as South Korea, Japan, and the European Union, have GAP certification for medicinal materials, and some are organized by industry associations. Certification of imported products is a kind of quality credit certification. Some domestic companies have also obtained relevant certifications.
Xiao Wei, chairman of Jiangsu Kangyuan Pharmaceutical Co., Ltd. suggested that not only high-risk varieties such as traditional Chinese medicine injections and medicinal materials used in basic pharmaceutical products should be all GAP-based medicinal materials, but also GAP base medicines should be used during the creation of new traditional Chinese medicines. The preferred standard is to ensure the quality of innovative Chinese medicines from the aspects of origin, processing and quality control standards. For the resources of commonly-used medicinal herbs whose development volume is greater than the reserve, in line with the principle of “who uses who growsâ€, the production enterprises must establish standardized planting bases for medicinal materials and maintain the balance between use and storage. The raw materials of Chinese Herbal Medicine used by tertiary hospitals must also use GAP base herbs or authentic herbs.
Xiao Wei also suggested that in order to encourage companies to use GAP base medicines, the government should give corporate policy support from product pricing, tendering, and clinical applications. For modern agricultural enterprises, which are mainly engaged in the cultivation, research, processing, and sales of medicinal herbs, enterprises should also be encouraged to apply for GAP acceptance. Through acceptance, certain incentive policies will be given.
According to Qin Mingjian, if the government increases the promotion of Chinese herbal medicine GAP, it will further stimulate the cultivation enthusiasm of Chinese herbal medicines, not only can improve the quality of medicinal materials, but also to some extent ease the pressure of rising prices of medicinal herbs.
Obviously, despite the fact that there is no clear plan for the promotion of the “Regulations for the Quality Management of Chinese Medicinal Plants (Trial)†(hereinafter referred to as the “Chinese Medicinal Materials GAPâ€) as mandatory certification like GMP, the government actively urges and fully promotes the industry and academia. Next, this industry norm is expected to usher in another rise. This also confirms that previous officials from the Ministry of Health stated that the government was prepared to increase the promotion of GAP certification for Chinese herbal medicines to ensure the sustainable development of herbal medicine resources.
Industry support
Regarding the latest progress in GAP certification, the reporter learned from the National Food and Drug Certification Review Center (hereinafter referred to as “the Centerâ€) that is currently responsible for carrying out GAP certification for Chinese herbal medicines. Sun Jinglin, director of the Central Inspection Division II, told reporters that experts from the center will inspect the certification of GAP certification for Chinese herbal medicines, and will be notified through the official website of SFDA for publicity.
Sun Jinglin said that at present, there is no assumption that the Chinese herbal medicine GAP certification as a compulsory certification.
The reporter then called Sichuan Good Doctor Pharmaceutical Group. The SFDA's latest issue of the first edition of the Chinese Medicinal Materials GAP certification announced that the company's subsidiary company's aconite production base has been certified as a Chinese herbal medicine GAP. Shen Yumei, vice president of Haoyao Pharmaceutical Group, said that although the cost of doing business according to GAP requirements will increase the cost of the company, the company’s confidence in the quality of its own products has also increased, and it has truly implemented the first link of quality of Chinese medicine in the land. The concept is more assured in terms of product quality stability and homogeneity.
In addition, Shen Yongmei also told reporters that Chinese medicines that use GAP-certified Chinese herbal medicines in domestic drug procurement can obtain certain points in some provinces. This allows companies to participate more actively in GAP certification of Chinese herbal medicines. Moreover, at present, there is also some understanding of the Chinese medicines GAP certification, which also increases the confidence in the export of products.
With the development of traditional Chinese medicine and the market demand for Chinese herbal medicines, the resources of herbal medicines have been seriously depleted, and the growth environment of Chinese herbal medicines resources has been destroyed. The resources of wild herbs have been continuously reduced, which has led to an increasingly prominent contradiction between the supply and demand of Chinese herbal medicines. The situation is very serious. In an interview, the reporter learned that Chinese herbal medicines should be planted and produced in accordance with the conditions of Chinese herbal medicine GAP specifications. The industry generally supports this.
The authoritative experts in GAP certification management of Chinese herbal medicines and the president of the Chinese Medicinal Organism GAP Research Promotion Association, Professor Zhou Ronghan, recently traveled frequently to Beijing to participate in technical seminars related to Chinese herbal medicines. Zhou Ronghan told reporters that at present, the Chinese herbal medicine industry is actively preparing to convene a commemorative conference to implement the 10th anniversary of China's implementation of GAP certification in 2012. It is reported that a number of domestic mainstream Chinese medicine companies have participated in the preparations for the conference.
Have twisted expectations and rejuvenation
The development of Chinese herbal medicine GAP during these years has not been easy.
In 2004, the first batch of 20 companies passed the GAP certification of Chinese herbal medicines. Among them, Tasly, Tong Ren Tang, and Te'an, etc. received certification for Salvia miltiorrhiza, ginseng and Panax notoginseng; in 2005, 8 companies passed certification; in 2006, there were 20 The home business is certified. In 3 years, 48 ​​companies passed the GAP certification of Chinese medicinal materials. At the 2006 World Health Organization's annual "Regional Collaborative Collaboration on Plant Medicines," GAP became the subject of intense debate.
However, only two companies and four companies passed certification in 2007 and 2008 respectively. This aspect was allegedly related to academic disputes at the time of GAP certification, and it was also suspected of coincidence with the “GAP†certification promoted by the CNCA.
In January 2006, the National Certification and Accreditation Administration formulated the “Guidelines for Good Agricultural Practice (GAP) Certification Implementation (Trial)â€. In August 2007, the CNCA amended the Good Agricultural Practice (GAP) and implemented it on January 1, 2008. The 561 companies in 25 provinces have already conducted pilot demonstrations of good agricultural practices certification. Currently, there are 410 certificates issued.
Up to now, only 75 companies have published GAP certifications for Chinese herbal medicines.
For the development and status quo of GAP certification of Chinese herbal medicines, Qin Mingjian, a professor of traditional Chinese medicine resources at the China Pharmaceutical University who has been paying attention to GAP certification for many years, told reporters that this is related to the difficulty and complexity of the GAP certification of Chinese herbal medicines. The majority of herbal medicine breeders are farmers, which are difficult to regulate and sensitive to interests. In addition, the investment involved in GAP certification of Chinese herbal medicines involves a relatively large amount of investment. The government has invested limited manpower and financial resources in pharmaceutical supervision. Therefore, relying on the government to promote Chinese herbal medicines GAP is not realistic at present. However, in the long run, with the development of the industry, it is an inevitable trend to implement a unified Chinese herbal medicine production specification.
Qin Mingjian further pointed out that at present, several countries and regions with rapid development of traditional drugs in the world, such as South Korea, Japan, and the European Union, have GAP certification for medicinal materials, and some are organized by industry associations. Certification of imported products is a kind of quality credit certification. Some domestic companies have also obtained relevant certifications.
Xiao Wei, chairman of Jiangsu Kangyuan Pharmaceutical Co., Ltd. suggested that not only high-risk varieties such as traditional Chinese medicine injections and medicinal materials used in basic pharmaceutical products should be all GAP-based medicinal materials, but also GAP base medicines should be used during the creation of new traditional Chinese medicines. The preferred standard is to ensure the quality of innovative Chinese medicines from the aspects of origin, processing and quality control standards. For the resources of commonly-used medicinal herbs whose development volume is greater than the reserve, in line with the principle of “who uses who growsâ€, the production enterprises must establish standardized planting bases for medicinal materials and maintain the balance between use and storage. The raw materials of Chinese Herbal Medicine used by tertiary hospitals must also use GAP base herbs or authentic herbs.
Xiao Wei also suggested that in order to encourage companies to use GAP base medicines, the government should give corporate policy support from product pricing, tendering, and clinical applications. For modern agricultural enterprises, which are mainly engaged in the cultivation, research, processing, and sales of medicinal herbs, enterprises should also be encouraged to apply for GAP acceptance. Through acceptance, certain incentive policies will be given.
According to Qin Mingjian, if the government increases the promotion of Chinese herbal medicine GAP, it will further stimulate the cultivation enthusiasm of Chinese herbal medicines, not only can improve the quality of medicinal materials, but also to some extent ease the pressure of rising prices of medicinal herbs.
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