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Traditional Chinese medicine formula granules are granules made from single Chinese medicine decoction pieces through water extraction, separation, concentration, drying, and granulation.
Under the guidance of TCM theory, after being formulated in accordance with TCM clinical prescriptions, they can be taken by patients and belong to the management of TCM decoction pieces.
Category
.
In recent years, with the continuous development of the traditional Chinese medicine industry, the traditional Chinese medicine formula granule industry has been expanding its market, while the process of building relevant national standards has been accelerating
.
Especially since February 10th, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine and other four departments jointly issued the "Announcement on Ending the Pilot Work of TCM Formula Granules", deciding to end the pilot work of TCM formula granules, and clarify the supervision after the completion of the pilot work.
Since the incident, in order to accelerate the implementation of the policy of traditional Chinese medicine prescription granules, various provincial drug regulatory departments have also begun to issue standards for traditional Chinese medicine prescription granules, and actively implement the requirements of the "Announcement"
.
At present, with the advent of November, the standards for traditional Chinese medicine formulation particles previously issued by many places have begun to be formally implemented
.
For example, since November 1, the Shaanxi Provincial Food and Drug Administration issued the "Shaanxi Provincial Traditional Chinese Medicine Formula Granule Standard" which has been formally implemented
.
It is understood that the document includes 197 provincial Chinese medicine formula granule standards such as Ai Ye
.
From an overall point of view, the published standards of 197 varieties are scientific and reasonable, the basis is clear, the feeding amount and main processes are clear, and the production volume is unified to 1000g
.
Among them, 194 varieties have established specific and overall control methods based on characteristic map methods
.
The industry believes that the implementation of the new standard marks the progress of the Shaanxi province's traditional Chinese medicine formula granule industry towards scientific, standardized, and industrialized, and promotes the inheritance and innovation of traditional Chinese medicine
.
On October 11, the Shandong Provincial Food and Drug Administration also issued the "Announcement on Issuing and Implementing Shandong Provincial Standards for TCM Formula Granules", which announced the first batch of 80 provincial standards for TCM formula granules
.
This batch of standards will be officially implemented on November 1, 2021
.
In addition to the above provinces, from a comprehensive perspective of the implementation details issued by various regions, while helping the continuous liberalization of traditional Chinese medicine formula particles, all regions are also further detailing the capacity requirements of manufacturers and emphasizing that manufacturers of traditional Chinese medicine formula particles should fulfill the whole life of medicine.
The main responsibility and related obligations of the cycle, strengthen risk management
.
In this context, for Chinese medicine companies, it is more necessary to fulfill the main responsibilities and related obligations of the whole life cycle of medicines, strengthen control in the production and management process, and ensure the quality and safety of Chinese medicine formula particles, so as to better promote the health of the industry.
Development
.
The analysis believes that in order to better promote the development of domestic industries, in the future, the country and even the locality will put forward higher requirements on the production, storage, and transportation of formula particles out of respect for traditional Chinese medicine and responsibility for patients.
And more specifications
.
These regulations, including national standards, are obviously conducive to solving the problems of past market confusion, repeated waste of research and development, and continuing to raise market thresholds, while also placing higher requirements on the production and quality control of enterprises
.
Under the guidance of TCM theory, after being formulated in accordance with TCM clinical prescriptions, they can be taken by patients and belong to the management of TCM decoction pieces.
Category
.
In recent years, with the continuous development of the traditional Chinese medicine industry, the traditional Chinese medicine formula granule industry has been expanding its market, while the process of building relevant national standards has been accelerating
.
Especially since February 10th, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine and other four departments jointly issued the "Announcement on Ending the Pilot Work of TCM Formula Granules", deciding to end the pilot work of TCM formula granules, and clarify the supervision after the completion of the pilot work.
Since the incident, in order to accelerate the implementation of the policy of traditional Chinese medicine prescription granules, various provincial drug regulatory departments have also begun to issue standards for traditional Chinese medicine prescription granules, and actively implement the requirements of the "Announcement"
.
At present, with the advent of November, the standards for traditional Chinese medicine formulation particles previously issued by many places have begun to be formally implemented
.
For example, since November 1, the Shaanxi Provincial Food and Drug Administration issued the "Shaanxi Provincial Traditional Chinese Medicine Formula Granule Standard" which has been formally implemented
.
It is understood that the document includes 197 provincial Chinese medicine formula granule standards such as Ai Ye
.
From an overall point of view, the published standards of 197 varieties are scientific and reasonable, the basis is clear, the feeding amount and main processes are clear, and the production volume is unified to 1000g
.
Among them, 194 varieties have established specific and overall control methods based on characteristic map methods
.
The industry believes that the implementation of the new standard marks the progress of the Shaanxi province's traditional Chinese medicine formula granule industry towards scientific, standardized, and industrialized, and promotes the inheritance and innovation of traditional Chinese medicine
.
On October 11, the Shandong Provincial Food and Drug Administration also issued the "Announcement on Issuing and Implementing Shandong Provincial Standards for TCM Formula Granules", which announced the first batch of 80 provincial standards for TCM formula granules
.
This batch of standards will be officially implemented on November 1, 2021
.
In addition to the above provinces, from a comprehensive perspective of the implementation details issued by various regions, while helping the continuous liberalization of traditional Chinese medicine formula particles, all regions are also further detailing the capacity requirements of manufacturers and emphasizing that manufacturers of traditional Chinese medicine formula particles should fulfill the whole life of medicine.
The main responsibility and related obligations of the cycle, strengthen risk management
.
In this context, for Chinese medicine companies, it is more necessary to fulfill the main responsibilities and related obligations of the whole life cycle of medicines, strengthen control in the production and management process, and ensure the quality and safety of Chinese medicine formula particles, so as to better promote the health of the industry.
Development
.
The analysis believes that in order to better promote the development of domestic industries, in the future, the country and even the locality will put forward higher requirements on the production, storage, and transportation of formula particles out of respect for traditional Chinese medicine and responsibility for patients.
And more specifications
.
These regulations, including national standards, are obviously conducive to solving the problems of past market confusion, repeated waste of research and development, and continuing to raise market thresholds, while also placing higher requirements on the production and quality control of enterprises
.
