Traditional Chinese medicine formula granules can only be sold after being filed with the provincial food and drug administration, and the filing progress has become a new starting line for the formula granule industry.

01standard

By the beginning of July, 200 national standards for formula granules had been issued, and all provinces except Xinjiang and Tibet had also issued their own provincial standards. The largest number of provincial standards was issued in Shanghai (349), with more than 300 in Hainan (341), and 9 provinces issued standards ranging from 200 to 300.
A hospital needs more than 400 kinds of formula granules to meet the basic needs of clinical prescription. By the beginning of July, the total number of standards (GB+provincial standards) in 11 provinces including Shanghai (549), Hainan (541) and Guangdong (472) had exceeded 400, that is, the number of standards in one third of the provinces in China was basically sufficient. In addition, the total number of standards in 18 provinces such as Shaanxi (397), Sichuan (397) and Gansu (393) is between 200 and 300, which can meet the needs of some clinical prescriptions and is not far from 400. (For details, see Figure 1) If provincial standards mutually recognized among provinces are added, more provinces exceed 400 standards. On September 16, 2021, Gansu Food and Drug Administration held a seminar on mutual recognition of provincial standards for Chinese medicine formula granules and reached a consensus. Nine provinces including Xinjiang, Qinghai, Shaanxi, Jilin, Shandong, Zhejiang, Jiangxi and Guangdong and Guangxi attended the meeting. In late March of this year, the Food and Drug Administration of Hebei Province also issued the Notice on Standardizing the Quality Standards for Formulated Granules of Traditional Chinese Medicine Released Outside the Province into the Working Procedures for Trial Implementation in this Province, clearly supporting the formulation granule manufacturers to jointly build and share the quality standards for formulated granules at the provincial level across provinces.

Next, as of the end of August, the filing progress of four former national pilot enterprises, such as Tianjiang, Yifang, Kangrentang and Sanjiu, will be compared and analyzed.

02put on file

1. Comparison of four enterprises

By the end of August, the total number of filing standards of Tianjiang and Yifang in all provinces exceeded 8,000, with 8,862 and 8,565 respectively, followed by Kangrentang and China Resources Sanjiu, with 7,825 and 6,416 standards filed respectively. The total number of national standards filing of the four enterprises is very similar, ranging from 5,000 to 6,000, but the number of provincial standards filing is quite different. (See Figure 2 for details)

The total number of records filed by two companies in two provinces has reached 400, and their sales can be described as "unimpeded", that is, the total number of records filed by Guangdong and Beijing Kangrentang in their respective places of registration is 413 and 400 respectively. The number of filing standards is 300 ~ 400, and Tianjiang and Yifang have the most, both exceeding 10 provinces, namely 16 provinces and 14 provinces, and Beijing Kangrentang and China Resources Sanjiu have 4 and 3 provinces respectively. If the number of filing standards is 200 ~ 300, three enterprises exceed 20 provinces, namely, Tianjiang, Yifang and Kangrentang are 25, 24 and 26 provinces respectively, and the three are very close, and China Resources Sanjiu is 17 provinces. (See Figure 3 for details)

Let’s look at the specific filing progress of various enterprises in various provinces.

2. Tianjiang

Jiangyin Tianjiang has registered 391 places in Jiangsu Province, only 9 places short of 400 places. There are 15 other provinces with more than 300 places, including Guangdong (381), Tibet (379) and Sichuan (370) with more than 370 places. There are 9 provinces with 200 ~ 300 records, among which Jilin (284), Inner Mongolia (279), Chongqing (272), Fujian (268) and Hubei (260) all have 260 or more. The situation in Hunan is quite special. Only Tianjiang and Yifang have filed 16 and 15 national standards respectively, while Kangrentang and Sanjiu have not yet filed in Hunan, which is related to the specific regulations of the province. (See Figure 4 for details)

3. One party

In addition to the 400 (413) registered places in Guangdong Province, the Guangdong side has also registered more than 300 in other 14 provinces, including more than 350 in Hainan (353), Jiangxi (353) and Shandong (351). There are 10 provinces with 200 ~ 300 records, including more than 260 in Beijing (295), Jilin (269), Ningxia (267) and Inner Mongolia (267). One party only filed 15 national standards in Hunan. (See Figure 5 for details)

4. Hong Yan Tong

Beijing Kangrentang has just registered 400 in Beijing, and registered 398 in Tibet, only two short of 400. In addition, the number of filings in Anhui (313) and Shaanxi (301) provinces exceeded 300. There are 22 provinces with 200 ~ 300 records, including more than 280 in Guangdong (296), Jiangxi (286), Qinghai (284), Shandong (283) and Hebei (282). Kang Rentang has no record in Hunan. (See Figure 6 for details)

5. Sanjiu

There are three provinces with more than 300 records of China Resources Sanjiu formula granules, except Guangdong (374 records) and Anhui (322 records) where the actual production place (Anhui China Resources Jinchan Pharmaceutical) is located, and Shaanxi (315 records) also exceeds 300 records. There are 14 provinces with 200 ~ 300 records, including more than 230 in Shandong (267), Sichuan (249), Liaoning (239), Chongqing (238) and Jiangxi (235). Sanjiu was not filed in Hunan either. (See Figure 7 for details)

The above is the filing situation as of the end of August. In fact, the standard filing has made new progress every day.

The progress of filing between enterprises has been widened, and enterprises with slower progress will not be far behind, and there may be cases where they come from behind. After all, the speed and quantity of filing have become the new competitiveness after the liberalization of the formula granule market.

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