The State Administration of Traditional Chinese Medicine issued a document!

Novice on the road, new regulations for Chinese medicine formula granules

01 Clear sales location

On November 16, the State Administration of Traditional Chinese Medicine issued the "Notice on Regulating the Clinical Use of TCM Formula Granules in Medical Institutions" (hereinafter referred to as "standards").

It is worth noting that this "Regulations" clearly pointed out that the health and traditional Chinese medicine authorities at all levels should regulate the use of Chinese medicine formula particles in medical institutions, and medical institutions that can provide Chinese medicine services after approval or filing can use Chinese medicine formula particles

Previously, regarding the sales places of Chinese medicine formula granules, the "Announcement" stipulated that "Chinese medicine formula granules shall not be sold outside medical institutions

After all, traditional Chinese medicine formula granules can only be sold in TCM hospitals (general hospitals) at the second and above level

Taking 2020 as an example, China has only 4,426 TCM hospitals, 72,000 TCM medical institutions, and TCM medical and health institutions with 920 million visits per year, while there are as many as 35,000 (including private) hospitals and 1.

The introduction of the "Regulations" further restricts the term "medical institution".

In addition, the "Specifications" require that "only physicians and village doctors in medical institutions who can prescribe TCM decoction pieces can prescribe TCM formula granules

To some extent, it may also be a clear definition of "medical institutions capable of providing Chinese medicine services

It is worth noting that on June 30 this year, the National Health Commission issued the "Opinions on Further Strengthening the Work of Traditional Chinese Medicine in General Hospitals to Promote the Coordinated Development of Traditional Chinese and Western Medicine" (hereinafter referred to as the "Opinions")

Tertiary general hospitals should all set up TCM clinical departments, TCM outpatient clinics and TCM beds, and TCM wards and TCM comprehensive treatment areas should be established if conditions permit, and TCM should be included in the multidisciplinary consultation system

The industry believes that this is a great benefit to the development of Chinese medicine, and that further increasing the proportion of hospitals providing Chinese medicine services will bring a greater development market for Chinese medicine

At present, it seems that Chinese medicine formula granules may become the first group of beneficiaries of the above-mentioned "Opinions

02 Novice, steady development

In addition to clarifying the places where TCM formula granules are used, the document also requires provincial TCM authorities to further refine the clinical reasonable and standardized use measures of TCM formula granules when cooperating with the provincial drug supervision and administration department to formulate rules for the management of TCM formula granules.

While putting forward further requirements to relevant local departments, it also emphasized the dominant position of Chinese herbal medicine

The "Specifications" point out that doctors should inform patients before prescribing prescriptions for traditional Chinese medicine granules to protect patients' right to know and to choose

This is not difficult to understand

No, according to the market data generated during the pilot process, many patients in the clinic have a high degree of acceptance due to the convenience of traditional Chinese medicine formula granules, but they must be wary of misuse due to ignorance, and this is for patients Just as important as the doctor
.

In this regard, the "Specifications" clearly pointed out that medical institutions should strengthen the training and assessment of the use of traditional Chinese medicine granules, establish a prescription review system for traditional Chinese medicine granules, and standardize doctors' prescription behavior
.
The Pharmaceutical Affairs Management and Pharmacotherapeutics Committee of medical institutions shall take the prescription reviews and evaluation results of traditional Chinese medicine formula granules as the basis for regular assessment by physicians
.

Regarding the potential risks exposed during the further large-scale use of TCM formula granules, the "Specifications" also made clear requirements: medical institutions should establish a routine monitoring and early warning system for the clinical application of TCM formula granules, and regularly or irregularly monitor the clinical application of TCM formula granules.
The clinical application situation is monitored; suspected adverse reactions should be reported in time to promote the standardized and reasonable application of traditional Chinese medicine formula particles
.

All in all, for the traditional Chinese medicine formula granules, it is still in the "new hands" stage, and "safe driving" must be the most important thing
.

Finally, the release of traditional Chinese medicine formula particles has opened a new market window for the entire Chinese medicine industry.
In addition to doctors and patients, there are companies themselves who need "safe driving"
.
For relevant pharmaceutical companies, while pouring into the market to share the cake, they must pay attention to "driving standards", on the one hand to ensure product quality, on the other hand, they must also regulate their operations
.

The "Specifications" particularly emphasizes that: in accordance with the principle of "the industry must manage the trade >
.