State Food and Drug Administration promotes high-quality development of traditional Chinese medicine industry

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"Today, there are more than 9000 varieties of traditional Chinese medicine in China, with 59000 approval numbers. As of 2018, the industrial scale of traditional Chinese medicine reached 919.008 billion billion yuan, accounting for 25.6 percent of the pharmaceutical industry. From 2003 to 2018, the State Food and Drug Administration undertook the review of about 3262 applications for registration of traditional Chinese medicine, including 2499 applications for clinical trials and 763 applications for listing." A few days ago, the State Food and Drug Administration Drug Registration Administration Department of Chinese Medicine and Ethnic Medicine Division Director Wang Hainan said.

He also pointed out that after years of work, China's traditional Chinese medicine industry has made great progress, the scientific nature of research and development has been further improved, and the foundation of innovative research and development has been continuously strengthened, which has not only trained talents who are familiar with drugs and clinical trial methodology, but also established a number of clinical trial institutions, which has made a significant impact in the world.

Build the whole chain supervision system to solve the corresponding problems

In October this year, the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" (hereinafter referred to as the "Opinions") was issued, this paper puts forward 20 specific opinions from six aspects: improving the service system of traditional Chinese medicine, giving full play to the unique role of traditional Chinese medicine in maintaining and promoting people's health, vigorously promoting the improvement of the quality of traditional Chinese medicine and the high-quality development of the industry, strengthening the construction of the talent team of traditional Chinese medicine, promoting the inheritance, opening and innovative development of traditional Chinese medicine, and reforming and improving the management system and mechanism of traditional Chinese medicine.

At the same time, the "opinion" clearly put forward, reform and improve the registration management of traditional Chinese medicine, strengthen the quality and safety supervision of traditional Chinese medicine. Implement the main responsibility of Chinese medicine production enterprises, establish a multi-departmental collaborative supervision mechanism, explore the establishment of a traceability system for the whole process of the production, circulation and use of Chinese medicinal materials, Chinese herbal pieces, and Chinese patent medicines. It will take about 5 years to gradually realize that the source and destination of key varieties of Chinese medicine can be traced., Responsibility can be investigated.

In this regard, Wang Hainan said: "The opinion can be said to be a programmatic document for the development of Chinese medicine for some time to come. Through the implementation of the reform tasks set out in the document, Chinese medicine can achieve better development, and some of the problems in our daily work that are not compatible with the development of the Chinese medicine industry can also be effectively solved."

Wang Hainan also pointed out: At present, my country has established a full-chain supervision system from Chinese medicine registration, review and approval, verification and inspection, sampling inspection, production and circulation to adverse reaction monitoring, and established a combination of regular inspection, unannounced inspection, and random inspection. Supervision model.

Strengthen quality supervision and achieve remarkable results

According to Wang Hainan, in recent years, the State Food and Drug Administration has introduced more than 40 departmental regulations, including drug registration management measures, under the guidance of the the People's Republic of China Traditional Chinese Medicine Law and the the People's Republic of China Drug Administration Law, in the supervision system of traditional Chinese medicine, covering all aspects of the whole life cycle of drug quality supervision, including traditional Chinese medicine, and has carried out five aspects of work.

The first is to promote the inheritance of traditional Chinese medicine. In May 2018, the approval and management regulations for the simplified registration of ancient classic prescription Chinese medicine compound preparations were issued, which clearly stipulated the registration of classic prescription preparations, simplified procedures, and reduction of clinical trials.

The second is to encourage innovation in traditional Chinese medicine. A number of technical guidelines have been issued to provide basic guidance for the development of clinical trials and the evaluation of effectiveness and safety of new drugs of traditional Chinese medicine, and to speed up the improvement of the evaluation technical standard system in line with the characteristics of traditional Chinese medicine.

The third is to promote the sustainable use of traditional Chinese medicine resources. Organize the revision of the quality management standards for the production of Chinese medicinal materials and promote the standardized planting of Chinese medicinal materials; in order to achieve the sustainable use of Chinese medicinal resources, the issuance of evaluation technical guidelines will help establish a traceability system.

Fourth, with Chinese herbal medicine as the main focus of supervision, through the extension of upstream and downstream to implement the main responsibility of enterprises, improve product quality. Issuing the technical guidelines for the revision of provincial-level Chinese medicine decoction pieces processing specifications to enhance quality controllability; actively promoting the drafting and formulation of national Chinese medicine decoction pieces processing specifications; in order to improve the quality of Chinese medicine decoction pieces, corresponding appendices are formulated in the drug production quality management specifications.

The fifth is to focus on building a team of full-time inspectors. At present, there are about 600 GMP inspectors.

"In order to continuously improve the products after they are put on the market, we have successively issued guiding principles such as the general name naming technology of Chinese patent medicines and the specification expression technology of Chinese patent medicines, and established a drug standard system with the Pharmacopoeia of the People's Republic of China as the core." Wang Hainan said that in the revised pharmacopoeia, 116 varieties of proprietary Chinese medicines have been added, 117 varieties of proprietary Chinese medicines have been revised, and 360 standards for herbal pieces have been revised, including 143 medicinal materials and 217 pieces, with a total of 2715 varieties of traditional Chinese medicines.

At present, the State Food and Drug Administration has made positive progress in the quality control of traditional Chinese medicine. Ma Shuangcheng, director of the China Institute for Food and Drug Control and the Institute for the Control of ethnic traditional Chinese Medicine, said: through technical means, a detection method of glue medicinal materials different from molecular biology identification has been established, which can test the main components of glue; the consistency standard for the detection of heavy metals and pesticide residues in botanical medicinal pieces has been established. At present, 33 kinds of pesticides are banned and 53 monomers are restricted. A testing platform has also been established for the quality and safety of ethnic drugs.

Carry out supervision and scientific construction to standardize the research and development of traditional Chinese medicine.

Regarding the challenges and problems faced in the work, Wang Hainan pointed out, "The research foundation of Chinese medicine in China is weak and there is a lack of strong technical support in regulatory science. Therefore, from 2018, we have established bases and centers for drug regulatory science in China Academy of Chinese Medical Sciences, Beijing University of Chinese Medicine, China Pharmaceutical University and other institutions to increase the construction of regulatory science."

Wang Hainan said: "In terms of registration, it is necessary to combine the universal requirements of drug registration management with the particularity of traditional Chinese medicine; in terms of quality control, it is necessary to establish a quality control and traceability system for the whole process of traditional Chinese medicine, and explore and study the overall quality evaluation and control methods of traditional Chinese medicine; in terms of approval ability, it is necessary to establish a priority review procedure in line with the characteristics of traditional Chinese medicine, and a selection mechanism based on clinical value; based on the reality of the reform of my country's drug review and approval system, the objective laws of drug research and development innovation and scientific evaluation, and gradually improve the regulatory system."

Wang Hainan also stressed: "After the implementation of the new drug management law, the full implementation of the drug marketing license holder system will play a good role in promoting the integration of industry resources and accelerating the promotion of industrial concentration. We need to change our philosophy and adjust our policies to provide sufficient space for technological innovation of Chinese medicine enterprises and solve the problem of insufficient innovation motivation and capacity of Chinese medicine enterprises."

Accelerating the Internationalization of Traditional Chinese Medicine and Establishing a Global Model

In addition, by adhering to the concept of scientific supervision, the State Food and Drug Administration has set a model of rational supervision of traditional drugs, traditional Chinese medicine and ethnic medicine in the world. By promoting the construction of a technical guiding principle system in line with the actual research and development of Chinese medicine in my country, my country has gradually established its leading position in the registration and management of international traditional medicines and herbs. Wang Hainan said: "at present, China has become the sponsor and member state of the Western Pacific Herbal Medicine Regulatory Forum and the WHO International Herbal Medicine Regulatory Cooperation Organization, and a variety of Chinese herbal medicine standards have entered the European Pharmacopoeia and the United States Pharmacopoeia."

It is worth mentioning that the State Food and Drug Administration has also revised and improved the Measures for the Administration of Imported Medicinal Materials. It is understood that the new measures will be implemented on January 1, 2020. In addition, the State Food and Drug Administration also conducted an assessment of the border port of imported medicinal materials in Keelung Pulan, Tibet, which facilitated the import of medicinal materials from countries along the Belt and Road to China.

"With the accelerated pace of internationalization of Chinese medicine, there are currently more than 10 Chinese medicine approved for marketing in China, to the European and American drug regulatory authorities to apply for registration, some varieties have been approved by the U.S. FDA, into clinical trials. The international registration of these Chinese medicine products has strongly promoted the improvement of the level of research on new Chinese medicine drugs in China." Wang Hainan said.