The implementation rules for the management of Chinese medicine formula granules are issued in many places. A large number of Chinese medicines are included in the medical insurance

With the advancement of the time for traditional Chinese medicine formula granules to enter the medical insurance, all provinces have begun to act

01 A large number of drugs will be included in medical insurance

01 A large number of drugs will be included in medical insurance

On October 27, the Sichuan Provincial Food and Drug Administration issued a notice on the issuance of the "Detailed Regulations for the Management of Traditional Chinese Medicine Formula Granules in Sichuan Province", which gave specific instructions on the management of various types of Chinese medicine prescription granules, such as variety registration, production, circulation and use supervision, and The notification of the regulations will be implemented on November 1
.

Coincidentally, the Yunnan Provincial Food and Drug Administration also today issued a notice on the management rules of traditional Chinese medicine formula granules
.

According to the regulations of the State Food and Drug Administration, the pilot work of traditional Chinese medicine formula granules will be ended on November 1
.

With the advancement of this time node, all provinces have begun to "act"

Previously, the State Food and Drug Administration issued the "Letter on the Proposal No.
4117 (Medical Sports No.
455) Reply to the Proposal No.
4117 (Medical Sports No.
455) of the Thirteenth National Committee of the Chinese People's Political Consultative Conference", clarifying the provincial level The medical insurance department can include part of the traditional Chinese medicine formula granules into the payment scope, and refer to the category B management
.

The State Food and Drug Administration stated that it will continue to improve product quality and clinical efficacy, continuously strengthen the standardized management of traditional Chinese medicine formula granules, coordinate relevant departments to improve relevant systems, create a fairer and better market environment, and promote the inheritance and innovation of traditional Chinese medicine
.

Recently, many provinces have issued relevant notices, and a large number of traditional Chinese medicines will be included in medical insurance from November 1st
.

Inner Mongolia

Inner Mongolia

On October 15th, the Medical Insurance Bureau of Inner Mongolia Autonomous Region issued the "Notice on Including TCM Formula Granules into the Autonomous Region's Medical Insurance Fund Payment Scope" stipulating that TCM formula granules corresponding to the types of TCM decoction pieces that have been included in the medical insurance payment scope will be included in the payment scope.
Refer to "Class B "Drugs" management
.

160 kinds of traditional Chinese medicine formula granules that meet the corresponding national drug standards were included in the first batch

Hunan

Hunan

On October 11, the Hunan Provincial Food and Drug Administration and the Hunan Provincial Administration of Traditional Chinese Medicine issued the "Implementation Opinions on Strengthening the Management of Traditional Chinese Medicine Granules in Hunan Province (Xiang Yao Jianfa﹝2021﹞32)", supporting the inclusion of Chinese medicine formula granules The payment scope of the provincial medical insurance fund
.

If the types of Chinese herbal medicines have been included in the scope of medical insurance payment, the Provincial Medical Insurance Bureau may comprehensively consider factors such as clinical needs, fund payment capacity and price, and after expert review, include the Chinese herbal medicine formula particles corresponding to Chinese herbal medicines into the payment scope, and refer to Category B management

It also stipulates that from November 1, 2021, Chinese medicine formula granules that do not have national drug standards or standards established by the Hunan Provincial Drug Administration shall not be marketed in Hunan Province, and Chinese medicine formula granules shall not be sold outside medical institutions
.

Guangxi

Guangxi

On September 13, the Medical Insurance Bureau of Guangxi Zhuang Autonomous Region issued the "Notice on Further Strengthening the Management of Guangxi Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Chinese Medicine and Ethnic Medicine Decoction Pieces Catalogue".
Based on 892 pieces of traditional Chinese medicine in the Catalogue (2020 Edition), 531 pieces of traditional Chinese medicine and ethnic medicine that meet the conditions and have Guangxi local standards will be included in the basic medical insurance (including maternity insurance) and work-related injury insurance funds
.

It is clearly stated that the notice will be implemented from November 1, 2021, and the payment scope and payment policies for traditional Chinese medicine and ethnic medicine decoction pieces in all coordinated areas will be abolished at the same time
.

In the future, if the state and autonomous region have new regulations, those regulations shall be followed

02  pharmaceutical companies more competitive

02  pharmaceutical companies more competitive

From a national perspective, each province has different policies and regulations on whether or not Chinese medicine formula granules are included in the medical insurance catalogue
.

Although many provinces have included traditional Chinese medicine formula granules in medical insurance, such as Shandong, Hubei and other places, there are still differences in policies in different places

Taking Shandong Province as an example, Chinese medicine formula granules are required to be managed in accordance with the "Class B drugs" in the medical insurance catalog.
The relevant medical insurance payment regulations shall be implemented with reference to the corresponding provisions of the Chinese medicine decoction in the national drug catalog, and no local adjustments are allowed
.

At the same time, Chinese medicine formula granules are also proposed as a supplement to Chinese medicine decoction pieces, and their prescriptions follow the prescription management regulations of Chinese medicine decoction pieces
.

During the trial period, the scope of application of the traditional Chinese medicine formula granules produced by the research pilot enterprises approved by Shandong Province and included in the medical insurance payment will be extended to medical institutions above the first level (including the first level)

The medical insurance catalogue stipulates whether drugs can be included in medical insurance: drugs that are clinically necessary, drugs that have a relatively good economic evaluation, and so on
.

It is worth noting that the equivalence of traditional Chinese medicine granules and traditional decoctions has been the focus of debate in the academic circles
.

Due to the uncertainty of the curative effect, the speed of traditional Chinese medicine formula granules into medical insurance is relatively slow

Previously, the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" issued by the State Food and Drug Administration will be formally implemented on November 1 this year
.

The announcement mentioned that the Chinese medicine formula granules will be included in the management of Chinese medicine decoction pieces, and medical insurance shall refer to the corresponding Chinese medicine decoction pieces
.

Undoubtedly, this will further promote the active use of traditional Chinese medicine granules by patients, and will also attract more companies to enter the market

According to the data of the Prospective Industry Research Institute, the market size of traditional Chinese medicine formula granules increased from 200 million yuan to 10.
7 billion yuan from 2006 to 2016, with a compound annual growth rate of 48.
9%
.
Although affected by the tightening of industry regulatory policies, the traditional Chinese medicine formula granule industry will continue to grow rapidly in the next five years.
It is estimated that by 2023, the industry scale will reach 49.
21 billion yuan
.

Judging from the 2020 annual reports of major pharmaceutical companies, the sales of traditional Chinese medicine formula granules such as China Traditional Chinese Medicine, China Resources Sanjiu, Hongri Pharmaceutical, and Shenwei Pharmaceutical have basically shown an upward trend
.

The industry believes that the introduction of Chinese medicine formula granules into medical insurance will be more conducive to the high-quality development of Chinese herbal medicines
.
As more pharmaceutical companies deploy in this field, competition will become more intense
.