SFDA Releases Notice to Regulate Development of Chinese Medicine Industry

The State Food and Drug Administration recently issued the "Regulations on Regulating the Production and Business Orders of Chinese Herbal Medicines to Severely Check and Punish Violations of Laws and Violations" (hereinafter referred to as the "Notice"), which requires strengthening the supervision of production and circulation in the Chinese medicine industry and ensuring the quality of the Chinese medicine industry is stable. The "Notice" put forward specific requirements from the following three aspects: strengthening the supervision and management of standardized production and operation of Chinese medicines, investigating and prosecuting counterfeit sales and other illegal and infringement activities, and strengthening organization and leadership in implementing supervision responsibilities.

The "Notice" pointed out that in recent years, the regulatory authorities have continued to increase the supervision and control of production and circulation in the Chinese medicine industry and strive to maintain the overall stability of the quality of Chinese medicine. However, with the increasingly fierce market competition, the contradiction between the production and demand of Chinese herbal medicines has intensified and the prices have fluctuated sharply. The problems in the production and circulation of Chinese medicine have become prominent, and the phenomenon of counterfeiting and sales has risen. Some Chinese medicine production and operation enterprises have reduced their requirements and allowed them to behave in a non-standard manner. This has facilitated counterfeit sales and even directly participated in illegal activities, seriously disrupting the order of production and operation of Chinese medicines, and directly affecting the safety and effectiveness of public drug use.

The "Notice" focuses on requiring Chinese companies in the industry to pay attention to the quality of Chinese medicine products. According to the relevant plans, by 2015, the total output value of the Chinese medicine industry will reach 590 billion yuan, which will gradually come to an end with the realization of the specific goals of Chinese medicine medical resources and services, but only if the quality of Chinese medicine products is stable and reliable.

In the area of ​​chemical drugs, the consistency assessment of generic drugs in the Chinese medicine industry being promoted by the relevant ministries and commissions is expected to push the quality of chemical drugs to a new level. In the just-started field of biopharmaceuticals, the country has also initiated preliminary work on the development of biosimilar guidelines. At present, most of the traditional Chinese medicine products in the market have a long clinical history. Due to various historical reasons, there are inconsistencies in quality and curative effect. Under the circumstances where people have increased their drug safety requirements and increasingly fierce market competition, it is very urgent to improve product quality and efficacy.

Herbal Extract

Plant extracts refers to substances extracted or processed from plants (all or part of plants) with appropriate solvents or methods. They can be used in pharmaceutical industry, food industry, daily chemical industry and other industries.

There is a conceptual intersection between plant extracts and Chinese herbal extracts. The raw materials of plant extracts in China mainly come from Chinese herbal medicine. Therefore, domestic plant extracts can also be called traditional Chinese medicine extracts to some extent. They are generally included in the category of traditional Chinese medicine products in China's export trade statistics.


Development History

China's plant extracts come from the traditional Chinese medicine industry, and the overall development time is relatively late. In the 1970s, some Chinese herbal medicine factories began to use mechanical equipment to extract active ingredients, but only as part of production, plant extracts have not been produced on a large scale. Until the 1990s, the international trend of returning to nature rose, and people began to tend to use natural plant products. During this period, China's foreign trade rose, and China's Plant Extract industry was getting better and better. In the 21st century, with the application of more advanced extraction methods such as enzymatic extraction, ultrasound, supercritical extraction, membrane separation technology and microwave extraction technology, the yield of extract has been greatly improved, and China's plant extract industry has entered a golden period of development. From 2010 to 2015, the production capacity and export volume of plant extracts increased steadily and rapidly every year, and the proportion of plant extracts in the export of traditional Chinese medicine also increased a lot. Since 2016, the market situation of plant extracts has changed.


Classification


1. According to the content of active ingredients, it can be divided into three categories: effective monomer extract, standard extract and ratio extract;

2. It is divided into glycosides, acids, polyphenols, polysaccharides, terpenes, flavonoids, alkaloids, etc;

3. According to the product form, it can be divided into vegetable oil, extract, powder, lens, etc.

4. According to the purpose, plant extracts can be divided into natural pigment products, traditional Chinese medicine extract products, extract products and concentrated products.

Application

The application scope of plant extracts has been very wide nowadays. In addition to traditional Chinese medicine products, with the gradual increase of people's trust and dependence on natural products, a large part of plant extracts have been used in health products and food ingredients. In addition, plant extracts have been used in cosmetics and feed in recent years.

Some of the best-selling plant extracts in the world have several classifications. For example, Rhodiola, ginkgo, ginseng extract, etc. are used in the fields of brain strengthening, intelligence, prevention and treatment of Alzheimer's disease; Green tea, Fructus aurantii Immaturus, apple and bitter melon polypeptide extract are applied to reduce weight, reduce blood sugar and prevent diabetes. Paclitaxel, tea polyphenols, theanine, bioflavonoids such as lycopene and Anthocyanin are used in the field of natural anti-cancer; Licorice, garlic, Astragalus membranaceus and soybean extracts are used in the field of human immune system.

Ashwaganda Root Extract, ,Sophora Japonica Extract, Hypericum Perforatum Extract, Salvia Miltiorrhiza Extract

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