With the continuous upgrading of the traditional Chinese medicine formula granule industry, pharmaceutical companies are facing stricter supervision

Chinese medicine formula granules refer to granules made from single Chinese medicine decoction pieces after water extraction, separation, concentration, drying, and granulation.
It is a kind of medicine granules commonly used in modern Chinese medicine clinics
.
After long-term and extensive clinical use, the current Chinese medicine formula granules are becoming more and more popular with patients due to their curative effect, convenient use, and flexible deployment
.
It is worth noting that in this context, in order to meet the needs of the management of traditional Chinese medicine formula particles under the new situation, various localities have also begun to publish documents to further regulate the production and clinical use of Chinese medicine formula particles and promote their industrial upgrading
.
For example, recently, the Xinjiang Uygur Autonomous Region Drug Administration, the Health Commission, and the Medical Security Bureau jointly issued the "Implementation Rules for the Management of Traditional Chinese Medicine Granules in the Xinjiang Uygur Autonomous Region (Trial)" (hereinafter referred to as the "Rules")
.
Among them, the "Detailed Rules" clarified the main status of sticking to traditional Chinese medicine decoction pieces, will support enterprises to maintain integrity and innovation, and encourage the development of traditional Chinese medicine formula granules and industrial technology upgrades
.
Also clarified the standard management of traditional Chinese medicine formula granules
.
According to the requirements of the "Detailed Regulations", the granules of Chinese medicine formula produced, sold and used in the autonomous region should meet the national drug standards
.
If there is no national drug standard, it shall comply with the standard set by the Autonomous Region Drug Administration
.
It is worth mentioning that, in order to ensure the quality and safety of traditional Chinese medicine formula granules, the "Detailed Rules" also strictly stipulates the requirements for the record management, production management, use management and supervision and management of Chinese medicine formula granules, and strengthen the supervision of the whole chain of Chinese medicine formula granules
.
The industry believes that the implementation of the "Detailed Rules" will effectively promote the more refined and institutionalized management of Xinjiang TCM formula granules
.
Of course, in addition to Xinjiang, many regions have recently introduced and implemented their own implementation rules for the management of traditional Chinese medicine formula granules
.
For example, the Jilin Provincial Drug Administration, the Provincial Administration of Traditional Chinese Medicine, the Provincial Health Commission, and the Provincial Medical Security Bureau have studied and formulated the "Implementation Rules for the Management of Jilin Province Traditional Chinese Medicine Formula Granules (Trial)" (hereinafter referred to as the "Implementation Rules") to improve the overall Provincial level of development of the traditional Chinese medicine formula granule industry to ensure the safety of the masses
.
The "Implementation Rules" came into effect on November 1st
.
In addition, since November 1st, the Hebei Provincial Drug Administration, the Provincial Administration of Traditional Chinese Medicine, the Provincial Health Commission, and the Provincial Medical Insurance Bureau jointly issued the "Hebei Province Traditional Chinese Medicine Formula Granule Management Implementation Rules (Trial)" has also been officially implemented
.
It is understood that the regulations in Henan Province also clearly stated that Chinese medicine formula granules must not be sold outside of medical institutions
.
Medical institutions shall not purchase undocumented Chinese medicine formula granules
.
The Chinese medicine formula granules used should be purchased through the provincial centralized drug procurement platform and online transactions
.
The traditional Chinese medicine formula granules used by medical institutions shall be distributed directly by the production enterprise, or be distributed by the pharmaceutical business enterprise that has storage and transportation conditions entrusted by the production enterprise
.
In general, judging from the current implementation rules issued by various provinces, in order to better promote the development of the domestic Chinese medicine formula granule industry, all regions have put forward higher requirements and more standards for its production, storage, and transportation links
.
For manufacturers, in this context, it is even more necessary to fulfill the main responsibilities and related obligations of the drug throughout the life cycle, strengthen control during the production and management process, and ensure the quality and safety of traditional Chinese medicine formula particles in order to better assist the company.
, And even the entire industry continues to develop in the direction of high quality
.