The management measures have been updated after 37 years, and the regional folk medicinal materials have ushered in "fine" management

On May 14, the State Food and Drug Administration and the State Administration of Traditional Chinese Medicine jointly issued the "Measures for the Management of Regional Folk Medicinal Materials" (hereinafter referred to as the "Measures"). The Measures will come into force on November 1, 2024, and the Measures for the Administration of Regional Folk Medicinal Materials (Trial) (hereinafter referred to as the Trial Measures) issued in 1987 shall be repealed at the same time.

Compared with the 8 articles of the trial measures, the "Measures" have a total of 5 chapters and 30 articles, which not only realizes the systematic update of the regional regulations on the management of folk medicinal materials, but also brings new solutions to the problems of concern to the industry such as the cross-provincial use of relevant medicinal materials. Wu Weigang, President of the Institute of Traditional Chinese Medicine of Jiuxin Traditional Chinese Medicine Group, commented that the "Measures" have clear logic, specific and clear provisions, and provide good guidelines for the industry to carry out their work. Bi Likezi, the registration and management department of the Xinjiang Uygur Autonomous Region Food and Drug Administration, believes that the "Measures" are comprehensive, detailed, operable and practical.

"It's been a long wait!" Qin Linxi, an industry expert, has worked in Tibetan medicine companies for a long time and is very concerned about the trend of relevant policies. In his view, the "Measures" reflect the respect and tolerance of regional folk medicinal materials, which is conducive to the development of Tibetan medicine and other ethnic medicines, and has positive significance for promoting the development of traditional Chinese medicine.

Establish a management requirements system

"Yunnan is rich in traditional Chinese medicine resources, and the folk are accustomed to using some locally grown Chinese medicinal materials that do not necessarily have national drug standards in long-term clinical practice. For example, compared with Bupleurum included in the Pharmacopoeia of the People's Republic of China, many traditional Chinese medicine practitioners in Yunnan use bamboo leaves and Bupleurum chinensis. Talking about the Chinese medicinal materials used by the local folk, Su Bao, president of the Yunnan Chinese herbal medicine planting and breeding industry association, introduced.

The mainland has a vast territory and diverse cultures, and the characteristic medicinal materials that have been used in various places for a long time are an important part of the treasure house of traditional Chinese medicine. The trial measures have been implemented for nearly 37 years and have played a positive role in promulgating provincial standards for medicinal materials and meeting the needs of regional clinical drug characteristics, however, some of its contents have not met the current needs.

"The trial measures were formulated in accordance with the earliest Drug Administration Law of the People's Republic of China on the mainland, with only eight articles, which delineated the boundary for 'what not to do', but did not specify what should be done." Wu Weigang said that the industry needs the practical needs of the detailed guidance practice of laws and regulations.

In recent years, the Law of the People's Republic of China on Traditional Chinese Medicine has been promulgated, the Drug Administration Law of the People's Republic of China has been revised, and the laws and regulations related to drug supervision have been systematically reconstructed. "As drug supervision enters a new stage of development, the drug management model has gradually changed from 'extensive' to 'fine', and some of the contents of the trial measures cannot meet the requirements of the current supervision of Chinese herbal medicines." Bilikzi said.

In response to the needs of industry development and regulatory work, the State Food and Drug Administration has put the revision of the trial measures on the agenda and promoted relevant work in conjunction with relevant departments. In this process, the State Food and Drug Administration not only solicited opinions from the public, but also organized industry associations, experts, and representatives of local regulatory departments to conduct discussions and study the revised manuscripts one by one. After revision and improvement, the "Measures" were officially released.

The term "regional folk medicinal materials" in the "Measures" refers to the Chinese herbal medicines that have been recorded in Materia Medica, medical records, prescriptions, etc., and are not included in the national drug standards and do not have drug registration standards, but have many years of medicinal habits in local areas. The term "traditional Chinese medicine" includes the medicine of ethnic minorities, and Chinese herbal medicines include the medicinal materials of ethnic minorities. The "Measures" implement the relevant laws and regulations, combined with the needs of the development of the industry, and systematically build a regional management system for folk medicinal materials.

"In terms of standard management, the whole life cycle management of provincial Chinese herbal medicine standards has been further standardized from the scope of medicinal materials, the name of medicinal materials, the filing of standards, the improvement of standards, and the abolition of standards; In terms of production and use management, the harvesting and processing, procurement and use, cross-provincial use, labeling, and implementation standards of regional folk medicinal materials have been clarified. In terms of supervision and management, it has clarified the main body and regulatory measures of regional folk medicinal materials, and at the same time, the provincial drug regulatory departments are encouraged to carry out dynamic monitoring and quality monitoring of medicinal materials resources...... "Wan Shun, Drug Registration Management and Science and Technology Department of Hunan Provincial Food and Drug Administration, believes that these provisions of the "Measures" are not only new, but also close to reality, so that the regulatory work has a starting point.

Promote the acceleration of standard construction

Standards are of great significance for the use and supervision of regional folk medicinal materials. The relevant provisions of the "Measures" on standard management have aroused the common concern of regulatory authorities and industry enterprises.

In the general provisions, the "Measures" clarify the overall requirements for the formulation of standards for regional folk medicinal materials, prohibit varieties that have no history of local habitual use or lack of safety, functional indications or research to be included in the provincial standards for Chinese herbal medicines, and set up a special chapter on standard management. "The Measures systematically standardize the formulation and management of provincial standards for Chinese herbal medicines with detailed provisions, and at the same time clarify the way for provincial standards for Chinese herbal medicines to be upgraded to national drug standards, forming a complete closed loop of standard management." Bilikzi said.

It is reported that the drug regulatory department of Xinjiang Uygur Autonomous Region attaches great importance to the construction of the standard system and continues to strengthen the standard management of provincial Chinese herbal medicines, which has played a good role in promoting the standardization and healthy development of the traditional Chinese medicine industry in Xinjiang. Therefore, Bilikzi is well aware of the importance of the standard management chapter of the Measures.

Wu Weigang believes that the improvement of the system of standard management of regional folk medicinal materials will help promote the construction of standards, and then promote the resource utilization and industrial development of related medicinal materials. He introduced that there are many varieties that are widely used and in high demand among the regional folk medicinal materials. However, due to the lack of herbal research, in-depth research, and untimely formulation of local standards, these varieties are faced with the embarrassing situation that large enterprises do not distribute and medical institutions do not use, and eventually they are mostly used as agricultural products to circulate and sell, and are used to make tea substitutes, etc., and their medicinal resource value has not been deeply developed.

"After the promulgation of the "Measures", the path of the construction of regional folk medicinal materials standards is clearer. For some large varieties of medicinal materials that urgently need to formulate standards, the construction of standards is expected to be accelerated. Wu Weigang said.

The Measures clarify the way for the provincial standards of Chinese herbal medicines to be upgraded to national drug standards, and stipulate that the provincial drug regulatory departments may organize research on the varieties included in the provincial standards for Chinese herbal medicines in accordance with the relevant technical requirements, propose draft standards, and apply to the State Pharmacopoeia Commission for new national drug standards, and the State Pharmacopoeia Commission will review them in accordance with relevant procedures. This made Wu Weigang particularly pleased. He bluntly said that in the past, it was actually "quite difficult" to transform the provincial Chinese herbal medicine standards into national drug standards. Now the "Measures" give a clear way, under the attraction of market demand, enterprises, drug regulatory departments and other parties work together, there will inevitably be a batch of varieties will be declared for national drug standards.

"The standard construction work should go to the front line and conduct in-depth research, so that the standards formed can better serve the masses in treating and preventing diseases, promote industrial development, and promote the integrity and innovation of traditional Chinese medicine." Su Bao expressed his expectations. Qin Linxi believes that if local standards want to be upgraded to national drug standards, they should do solid research and research on historical application and safety research in accordance with regulations.

Solve practical use problems

Over the years, the industry has had certain demands for simplifying the management of the cross-provincial use of regional folk medicinal materials, and there are also certain needs for doctors practicing across provinces and preparing prescriptions in medical institutions in clinical practice. The "Measures" no longer approve the cross-provincial use of regional folk medicinal materials.

The "Measures" stipulate that, in principle, regional folk medicinal materials should be used within the administrative area of the provincial drug regulatory department where the place of origin is located, and if there is a clinical use demand, they can be used across provinces (autonomous regions and municipalities directly under the Central Government), and at the same time, traceability requirements are put forward for the cross-provincial use of traditional Chinese medicine decoction pieces and preparations related to regional folk medicinal materials, so as to control the risks that may be brought about by cross-provincial use.

Many people praised it. "It's a good move." Wu Weigang believes that in the past, the cross-provincial sales of regional folk medicinal materials needed to be transferred to the relevant provincial departments for approval, but in fact, this path was difficult to follow. The Measures address this issue. In his opinion, as long as the regional folk medicinal materials that do have clinical needs are properly promoted, the market for cross-provincial use and sales will not be too bad. As for traceability, this is the general trend of strengthening drug quality management, and there is not much technical challenge to achieve.

For the use of regional folk medicinal materials, in addition to canceling the approval of the cross-provincial use of medicinal materials, the Measures also allow the sale of regional folk medicinal materials in urban and rural bazaars, except for the toxic Chinese medicinal materials included in the "Measures for the Administration of Toxic Drugs for Medical Use" and the Chinese herbal medicines that are clearly recorded as highly toxic and highly toxic in the provincial standards for Chinese herbal medicines.

While noting the benefits given by the "Measures", we should also pay attention to its emphasis on the quality and safety of production and use: the "Measures" put forward hardware facilities and personnel capacity requirements for Chinese herbal medicine manufacturers that directly purchase regional folk medicinal materials, clarify the packaging requirements for regional folk medicinal materials produced and sold by Chinese herbal medicine production enterprises, and clarify the provincial standards for Chinese herbal medicines in the place of use or production of regional folk medicinal materials.

Such provisions are necessary. Taking the packaging of the above-mentioned regional folk medicinal materials as an example, the "Measures" require that the product name, origin (marked to the county-level administrative district), harvest (processing) date, implementation standards and other contents be indicated. Qin Linxi analyzed that there may be a phenomenon of "foreign bodies with the same name" in the customary medicinal materials in different regions, and the relevant content is required to be labeled for the sake of ensuring the safety of drug use, and it is also convenient for the regulatory authorities to supervise. Qin Linxi believes that drug safety is closely related to the health of the people, and strict quality and safety requirements are conducive to the long-term development of regional folk medicinal materials.

Source: China Food and Drug Network