“Any standard, in addition to legal regulations, must also be feasible, operable and practical for enterprise production. Reasonable Carrying out the standard formulation and filing of traditional Chinese medicine formula granules is the basis for maintaining the healthy and orderly development of the industry.” This year’s two sessions, Zhang Boli, deputy to the National People’s Congress, academician of the Chinese Academy of Engineering, and leader of the national key discipline of traditional Chinese medicine internal medicine, is “the healthy and sustainable development of the traditional Chinese medicine formula granule industry.” development” recommendations.
In order to promote the modernization and internationalization of traditional Chinese medicine, the standardization and standardization of traditional Chinese medicine granules are included in the national strategy implementation. Under the guidance of the State Drug Administration, relevant pilot enterprises have innovated the research and development of traditional Chinese medicine granules by using modern scientific and technological means in accordance with the requirements of the pilot work and on the basis of inheriting traditional traditional Chinese medicine theories, and have achieved industrialization. According to the relevant requirements of the “Announcement on Ending the Pilot Work of Traditional Chinese Medicine Formula Granules” jointly issued by the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine and other four departments, from November 1, 2021, the production enterprises of traditional Chinese medicine formula granules must comply with the national and provincial regulations. Standard production formula granules.
Subsequently, the State Food and Drug Administration promulgated 196 national standards for traditional Chinese medicine formula granules, and each province has successively formulated detailed rules for the management of traditional Chinese medicine formula granules, and successively carried out provincial standard issuance and filing review. However, judging from the implementation of the standard release and filing review of traditional Chinese medicine formula granules in various provinces, the progress of the work is uneven. There are more than 200 standards announced and released by many provinces, and there are more than 60 standards, involving a total of 440 varieties. Some provinces have approved nearly 200 varieties of enterprises for record, while others have only approved a few varieties.
In addition, due to the different national and provincial standards and requirements, the filing materials need to be studied and reported separately by province, resulting in a huge workload for enterprises and overwhelmed with coping. According to Zhang Boli’s investigation and understanding, the current problems mainly exist in four aspects.
First, the formulation of national standards for traditional Chinese medicine formula granules is slow and cannot meet the needs of clinical medication. At present, the State Drug Administration has officially issued 196 quality standards for traditional Chinese medicine formula granules. However, due to processed products, there are multiple standards for one product in the 196 standards. Therefore, the actual variety is only 136 flavors, which is still far from the 400 flavors commonly used in clinical practice. , resulting in the lack of varieties when the doctor prescribes, which cannot meet the needs of clinical medication.
Second, the national and provincial standards of traditional Chinese medicine formula granules have too high requirements on the raw medicinal materials and the quantity of test indicators for the content of formula granules, resulting in increased production costs and difficulty in quality control. For example, the currently promulgated national standards require much higher standards for raw medicinal materials to be used than the Pharmacopoeia standards, and the number of test indicators for the content of formula granules is much higher than the Pharmacopoeia standards, which greatly increases the cost.
Third, provincial requirements for formulation of traditional Chinese medicine formula granules are not uniform, and enterprises are struggling to cope, resulting in a waste of resources. At present, 29 provinces have issued a total of 4,326 provincial standards. Except for duplicate varieties, there are actually 428 varieties. In addition, 75 varieties are in the publicity period, so the total provincial standard involves 503 varieties. Because the provincial standards of traditional Chinese medicine formula granules are formulated by the provincial drug administration departments, and the requirements of the provincial standards are quite different, and the provincial standards of the same variety are inconsistent, resulting in a chaotic situation of the same variety and multiple specifications.
Fourthly, the currently implemented national standard based on “manufactured volume” as the basis for doctors’ prescriptions has hidden safety hazards and high prices for clinical drug use.
In order to develop the traditional Chinese medicine formula granules industry in a healthy way, reasonably carry out the formulation and filing of traditional Chinese medicine formula granules standards, and avoid resource waste and market irregularities, Zhang Boli put forward four suggestions:
First of all , further intensify the formulation of national standards for traditional Chinese medicine formula granules and speed up the filing speed, and a batch of mature batches will be issued. In terms of varieties, priority should be given to varieties with high frequency of clinical use and large amount of use, and strive to use about 1 year to make the standards promulgated by the state reach about 500.
Secondly, rationally formulate the standards for the raw materials of traditional Chinese medicine formula granules and the number of test indicators for the content of the formula granules. On the premise of maintaining the quality of traditional Chinese medicine formula granules, the standards for the use of raw medicinal materials and the number of test indicators for the content of formula granules should be reasonably formulated.
Third, cancel the formulation and filing of provincial standards for traditional Chinese medicine granules to avoid duplication of research and waste of social resources. Because the provincial standards are only transitional standards, once the new national standards are promulgated, the original provincial standards will be revoked, which not only increases the unnecessary burden of enterprises, but also causes a great waste of preliminary research resources. For the varieties that have not entered the national standard, the enterprise standards of the six pilot enterprises of national Chinese medicine formula granules approved by the State Food and Drug Administration can be temporarily implemented.
Finally, re-evaluate the currently implemented national standard that is based on “production volume” as the basis for doctors’ prescriptions, so as to avoid potential safety hazards and high prices for medication.
“In order not to change the traditional prescription habits of traditional Chinese medicine doctors, but also to inherit thousands of years of traditional Chinese medicine culture, it is recommended that the State Food and Drug Administration organize relevant departments and experts to combine 20 years of clinical use of traditional Chinese medicine formula granules. According to the actual situation, discuss and formulate relatively safe quality standards to ensure the safety and effectiveness of clinical medication.” Zhang Boli said.
Editor in charge: Lin Jing