Full release of Chinese medicine formula granules (part 1)

From now on, the trial of traditional Chinese medicine formula granules has officially ended

From November 1st, the 27-year-long trial of traditional Chinese medicine formula granules has been completely ended.

Since Guangdong Yifang Pharmaceutical was designated as a "pilot unit for the research and development of Chinese medicine formula granules" by the Department of Science and Technology of the State Administration of Traditional Chinese Medicine in March 1994, the experiment of Chinese medicine formula granules has been 27 years

Due to space limitations, this article only analyzes the quality standards and sales regulations that directly affect sales.

01QualityStandard

1.

One of the important changes after the implementation of the filing system is that it will no longer be able to produce and sell according to corporate standards in the future.

So, how many quality standards have been issued so far? Can it meet the needs of sales?

According to the author’s statistics, as of today, there are a total of 3325 Chinese medicine formula granule standards that have been studied nationwide, of which 1,389 have been officially released and implemented (196 in two batches at the national level, and 1193 at the provincial level), and are still under research (that is, national Level 246) Monks are in the public announcement (that is, 1690 at the provincial level), a total of 1,936 (Figure 1)

Of course, the varieties studied between provinces have been duplicated.

In fact, the quality standards in many provincial public announcements are accelerating the speed of conversion.

In addition, in order to speed up the mutual recognition of provincial standards and establish a joint construction and sharing mechanism for provincial standards, a seminar on mutual recognition of provincial standards for traditional Chinese medicine formula granules was held in Longxi County, Dingxi City on September 16, and the following consensus was reached:

1.

2.

3.

4.

2.

Since the issuance of the "Announcement", all provinces except Xinjiang, Tibet, Jilin, Tianjin, Chongqing and Fujian have publicized or issued their own formula granule standards

As of today, 1193 standards in 14 provinces have been officially released.

In addition, there are 1,690 provincial standards still under public announcement.

Some provinces have also set transition periods of different lengths for corporate standards, such as half a year in Shanghai and 1 year in Guangxi, while Hubei and Guizhou also allow products that have been filed before November 1 to be used until the product's validity period
.

02 Sales

The "Announcement" stipulates that "Traditional Chinese medicine formula granules shall not be sold outside medical institutions", that is, they can be sold in all medical institutions.
Although the enforcement is not very strict, they can only be sold in second-level and above Chinese medicine hospitals (general hospitals).
Therefore, after the "Announcement", theoretically, the scope of permitted sales of Chinese medicine formula granules will be greatly expanded
.

Taking 2020 as an example, my country 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.
03 million medical institutions across the country.
7.
7 billion visits of homes and consultations, 8 times, 14 times and 8.
4 times that of Chinese medicine (Figure 3)

The implementation of the filing system for Chinese medicine formula granules, unifying standards and expanding the scope of sales provide a broader space for companies interested in the development of the industry, and also provide a guarantee for the safety of patients' medication
.