Medical network on December 27th - from October launch the "healthy China 2030" planning outline ", released in November to the pharmaceutical industry development planning guide, the white paper on "China's traditional Chinese medicine", and then to just released by the traditional Chinese medicine act, relevant policies of Chinese medicine in the fourth quarter of 2016 intensive release. Relevant policy shows that traditional Chinese medicine in the position and role of the economic and social development more and more important, Chinese medicine industry has ushered in the new historical highs.
The state formulates the target of Chinese medicine in 2020 for everyone enjoys the basic services of traditional Chinese medicine; 2030 targets for services to achieve full coverage of traditional Chinese medicine, and promote Chinese medicine service around the world. More than two goals was very grand, which is based on: during the "twelfth five-year" Chinese medicine innovation ability significantly increased, the whole process of Chinese traditional medicine quality control level; Tu won the Nobel Prize means the innovation of traditional Chinese medicine international further endorsed; In addition, in the face of increasingly aggravation of the health care payment pressure, price advantage of Chinese medicine is the cause of national developing traditional Chinese medicine.
In such a big background, the author from traditional Chinese medicine, Chinese herbal medicine (slices) innovation and internationalization of traditional Chinese medicine (TCM) in three aspects, analysis of project opportunities in traditional Chinese medicine industry in the future. The author thinks that, all the planning is for the Chinese medicine major brands and internationalization.
Table: issued relevant policy of traditional Chinese medicine in 2016
"Chinese medicine innovation"
What is the direction of the project of modern traditional Chinese medicine?
"Adhere to the inheritance and innovation" is the development of traditional Chinese medicine, the subject must be to learn the state has encouraged the use of modern science and technology research and development of traditional Chinese patent medicine, this means that the development of proprietary Chinese medicine need to keep the special advantage and actively use modern science and technology. And specific to the project, what is "inheritance" and "innovation" is the project?
In "Chinese medicine innovation" project, national sword refers to the advantages of traditional Chinese medicine diseases such as cardiovascular disease, autoimmune diseases, especially disease, digestive department disease areas, mining classic square, compound, active ingredients and traditional Chinese medicine effective parts research focus on variety, quality is stable and controllable, outstanding clinical advantages of modern traditional Chinese medicine (TCM). More of the pharmaceutical industry development planning guide is put forward to construction and integration of traditional Chinese medicine (TCM) chemical into depots, the innovation of the traditional Chinese medicine (TCM) this means that the world is in the direction of natural medicine chemistry research, the Chinese native medicine ingredient scale efficient separation and preparation technology development as the key objective is to confirm this.
It is important to note that by traditional Chinese medicine to evaluate to discover new indication also is a kind of innovative approach: in view of the listed species, using the modern science and technology, carry out drug post-marketing efficacy, safety, preparation process and quality control and evaluation, dig the clinical value of therapeutic areas clear advantage, the development of new indications.
Indications mining ways, "prevention" is together with drugs already on the market of new drug of TCM focused on the direction, including but not limited to, combined with chemical medicine research prevention and control of major difficult diseases, major infectious diseases; And the common disease, frequently-occurring disease, chronic disease prevention and control of Chinese medicine, it was during the "twelfth five-year" obtain good effect of traditional Chinese medicine disease areas.
Derived from the ancient classic square of traditional Chinese medicine compound preparations of secondary development is also worth attention. According to the new "law of Chinese medicine, ancient classic square is still widely used, curative effect, has obvious characteristic and advantages of classics written in ancient Chinese medicine prescriptions. This kind of prescription when applying for drug approval number, can only provide non-clinical safety study materials, but the specific catalogue shall be formulated jointly by the competent department of traditional Chinese medicine pharmaceutical supervisory and administrative department under the state council, the directory is expected in the short term will not wide open. This kind of compound preparations from the oral to external use can be avoided if clinical concern will be the enterprise, from clinical and is suitable for the pediatric compound preparations will be hot spots of firms.
Industrial innovation, the national support accord with the characteristics of traditional Chinese medicine slow release, the skin and mucous membrane to medicine, physical modification and new preparation technology such as mask taste. , the slow controlled release technology is more suitable for the development of the disease of heart head blood-vessel, digestive department disease, medication, the skin and mucosal drug delivery is suitable for the development of autoimmune disease, especially medicine, mask taste is more for the development of TCM pediatrics preparations. Physical modification of TCM refers to use spray drying, fluidized bed, mechanical grinding pressure, physical and mechanical methods, such as powder deposition by modifying the surface of the Chinese native medicine preparation raw material processing, change the Chinese native medicine preparation the poor physical properties of raw material, so that to improve the safety, efficacy and stability of the Chinese native medicine preparation, physical modification of TCM and focuses on the development of Chinese medicine extract for preparation of traditional Chinese medicine preparation raw material.
[back] "twelfth five-year" of Chinese medicine preparations
In 2015, the Chinese medicine gross value of industrial output 786.6 billion yuan, accounting for 28.55% of the medicine industry scale, become a new economic growth point. The domestic Chinese medicine national drug approval number about 60000, by 2088 through drug production quality management practices (GMP) certification of Chinese pharmaceutical enterprises, including the pill, powder, plaster, Dan and other traditional dosage form and dropping pill, tablet, furthermore, capsules and other 40 kinds of dosage forms. During the period of "twelfth five-year", China's basic established on the basis of the medicinal material production, industry as the main body, as a link to a business system of modern Chinese medicine industry.
The main contribution of Chinese medicine field, preventing and curing the common disease, frequently-occurring disease, complicated illnesses in major epidemic prevention and emergent public events also play an important role in medical treatment, such as the curative effect of treatment of infectious atypical pneumonia praise the world health organization. The doctor of traditional Chinese medicine in the treatment of influenza a (H1N1) excellent results drew international attention. At the same time, traditional Chinese medicine in prevention and control of AIDS, hand, foot and mouth disease, people H7N9 infection avian flu and other infectious diseases, as well as the wenchuan earthquake in sichuan, gansu zhouqu super-large public emergency medical treatment such as mud-rock flow, has played a unique role. For arsenic in traditional Chinese medicine agent combined with western medicine for use in acute promyelocytic leukemia curative effect is improved obviously, lanotte, Chen zhu, won the seventh SAN jie er ji cancer research innovation achievement award.
Traditional Chinese medicine and Chinese medicine yinpian 】 【
Quality control is still the main propositions
"Much starker choices-and graver consequences-in planning" is still a cliche to medicinal materials and Chinese medicines sliced and prepared for decoction quality control from the source base, to enhance the level of quality of traditional Chinese medicine (TCM) : promote large Chinese standardization production and the processing technology, the construction of the whole process of Chinese medicinal materials traceability system, perfecting Chinese medicine quality standard system, so as to enhance the level of traditional Chinese medicine quality control in the whole industry chain and finally achieve the goal of improve the quality of TCM products homogeneity and controllability.
Traditional Chinese medicine resources sustainable utilization plan is still planning the point. To carry out national census of resource of traditional Chinese medicine (TCM), the establishment of traditional Chinese medicine resources dynamic monitoring and technical service network, established germplasm resources protection system of Chinese medicine, medicinal germplasm resources and biodiversity protection.
Although the country no longer require production of GAP certification, but from the perspective of sustainable development, if the enterprise's main Chinese medicine effective parts not available through synthetic products, enterprises should strategic layout construction standardization authentic traditional Chinese medicinal materials planting breeding base, especially the authentic Chinese herbal medicine varieties, actively establish a geographical indication product brand.
In addition, the 2015 edition pharmacopeia has improved the testing standard of the pesticide residue, and check the cost of increased the industry chain. The new law of traditional Chinese medicine is put forward in the process of Chinese herbal medicine planting shall be forbidden to use highly toxic, high toxic pesticides. This means control of pesticide and fertilizer is expected in the future also will be more strict. Enterprise key layout authentic herbs planting breeding base, will be better able to manage medicine.
In view of the endangered rare medicinal materials, development of artificial breeding technology, especially to promote musk, aloes, Chinese caterpillar fungus and other products of wild plant breeding. For the shortage of traditional Chinese medicine, the country and even to encourage enterprises to invest in overseas acquisitions or construction production base, make full use of environmental resources abroad, which means that Chinese traditional medicine enterprises may be increased in southeast Asia and Africa and other ecological environment is relatively good and low cost of investment field of development of Chinese medicine planting industry.
In addition to basic drugs, Chinese medicine yinpian and traditional Chinese medicine of traditional Chinese medicine injection quality improvement, large varieties of traditional Chinese medicine production quality control standards and product standards and improve the quality of the product upgrade project plan of the project.
[back] "twelfth five-year" Chinese medicine resource survey results
At present, China's census of resource of traditional Chinese medicine (TCM) has been set up by a center platform, 28 center, 65 monitoring stations at the provincial level of traditional Chinese medicine resources dynamic monitoring information and technology service system, and 16 Chinese seed seedling breeding base and 2 germplasm repository.
The internationalization of traditional Chinese medicine (TCM) 】
Quality improvement and Chinese medicine major brands
Traditional Chinese medicine (TCM) want to use "neighbourhood" policy abroad, the key is to solve the problem of drug safety, mainly in the quality standard, effectiveness, safety, etc. Innovation and Chinese materia medica quality improvement for the development of international standards for traditional Chinese medicine, so as to create high quality Chinese medicine brand and encourage the international registration of Chinese medicine, leading the Chinese medicine enterprises to go out and expectations during the period of "much starker choices-and graver consequences-in" more Chinese medicine market in developed countries.
In health care under the background of ability to pay is close to saturation, chemical medicine new drug development for clinical curative effect of superior effect for enterprise pressure, chemical generics will face a vicious price competition, "control" from the effective chemical components of traditional Chinese medicine (TCM) mining direction to have research and development of new drugs in one direction.
However, natural medicine research and development direction is at least a 10 ~ 15 years, in the short term may be more difficult to see the results Chinese medicine widespread outbreaks. In fact, our production projects do not lack of natural medicine preclinical, but not enough in-depth research such as target, mechanism, the enterprise can't rush into, in the final analysis is the enterprise lack of talents of project evaluation. Big brands and international enterprises want to achievement of Chinese medicine Chinese traditional medicine, scientists to guide product development planning of enterprises are more likely to succeed.
[back] "twelfth five-year" internationalization of traditional Chinese medicine (TCM)
The paper according to the China's traditional Chinese medicine, Chinese medicine has spread to 183 countries and regions. Among them, the traditional Chinese medicine gradually into the international medical system, has been in Russia, Cuba, Vietnam, Singapore and the united Arab emirates and other countries in the form of drug registration. China healthcare chamber of commerce and other multilateral efforts, as of May 2016, including ginseng, dried tangerine or orange peel, atractylodes, radix et rhizoma rhei, pink flower, giant knotweed, notoginseng, etc. 66 kinds of Chinese medicinal materials into the European pharmacopoeia.
There were pioneers in Europe and the international mainstream medicine for traditional Chinese medicine market efforts.
Lanzhou Buddha goodness in 2011 to simplify the enrichment angelica pills eu traditional herbal registration ECTD formally submit the application to the Swedish national drug administration, become the first domestic in the European Union to apply for the registration of proprietary Chinese medicine.
Chengdu biological research and chengdu mondial pharmaceutical development and production of "mondial kang capsule" effort to eu registered 2012, is China's independent intellectual property rights therapeutic drugs into the market in developed countries for the first time.
Tasly compound danshen dropping pill Ⅲ clinical trial project in the United States, Canada, Russia, Ukraine, belarus, Georgia, Mexico, Brazil and China Taiwan 9 countries and regions, 127 clinical center smoothly; Winning the European plant salvia miltiorrhiza capsule drug registration certificate. |
