Identification procedure of ethnic medicine

Municipal Health and Wellness Committees and Chinese Medicine Bureaus:

In order to speed up the inheritance, innovation and development of traditional Chinese medicine and ethnic medicine in Guangxi, and promote the identification of ethnic medicine in Guangxi, the Bureau of Traditional Chinese Medicine of the Autonomous Region, combined with the actual situation in Guangxi, organized the Guangxi Ethnic Medicine Expert Committee to formulate and adopt the Identification Procedure of Guangxi Ethnic Medicine (Trial) and the Identification Standard of Guangxi Ethnic Medicine (Trial), which are hereby printed and distributed to you.

Guangxi zhuangzu autonomous region traditional Chinese medicine management bureau

July 2022 13

Guangxi Ethnic Medicine Appraisal Procedure (Trial)

According to the requirements of the Regulations on Traditional Chinese Medicine in Guangxi Zhuang Autonomous Region and the Three-year Action Implementation Plan for the Revitalization and Development of Guangxi Zhuang Medicine (202 1-2023), in order to speed up the inheritance and innovation of traditional Chinese medicine and ethnic medicine in Guangxi, standardize the declaration, review and release of Guangxi ethnic medicine, optimize the working procedures and strengthen service guidance, the working procedures for the identification of Guangxi ethnic medicine are formulated as follows: 1. Select a number of ethnic medicines with strong medical characteristics, which are safe, effective and economical, promote the key drugs with advantages in our region to enter the national medical insurance catalogue and the national essential drugs catalogue, and promote the high-quality development of the ethnic medicine industry in our region. Two. Identification procedure (1) project declaration. Relevant pharmaceutical enterprises in Guangxi choose the varieties of finished medicine preparations that meet the Guangxi Ethnic Medicine Identification Standard (Trial), fill in the Declaration of Guangxi Ethnic Medicine, and submit it to the office of Guangxi Ethnic Medicine Expert Committee together with other application materials.

(2) Project review. Guangxi Ethnic Medicine Expert Committee holds irregular meetings to review the drugs declared by Guangxi enterprises one by one and issue evaluation opinions, that is, "agree to identify" or "disagree to identify". The national medicine that has not passed the review shall issue a written opinion to the reporting unit, explaining the reasons for not passing.

(3) publicity of the results. The publicity of the proposed national medicine will last for 5 working days. If there is any objection to the publicity, the office of Guangxi Ethnic Medicine Expert Committee will organize experts to review it again.

(4) The results are announced. Ethnic medicine that has no objection to publicity is published in the name of Guangxi Zhuang Autonomous Region Administration of Traditional Chinese Medicine. Three. The application materials require (1) Guangxi ethnic medicine declaration.

(2) A copy of the business license and organization code certificate of the applicant.

(3) A copy of the approval document of the drug supervision and administration department that declared the drug.

(four) commissioned research, it is necessary to provide a copy of the qualification certificate of the entrusting unit and the cooperation agreement signed by both parties.

(5) A self-assurance statement on the authenticity of the application materials, including a commitment to bear legal responsibility for false information.

Four, the identification procedures from the date of promulgation, the trial period of 2 years.

Guangxi Ethnic Medicine Identification Standard (Trial)

First, the selected varieties must meet the following three conditions.

(1) has the "three characteristics" of national medicine (nationality, tradition and region), that is, the prescription source should be the folk prescription or secret recipe of Zhuang Yao and other ethnic groups in Guangxi, and the ethnic areas should have traditional usage habits;

(2) The prescription of the patent medicine preparation contains a certain proportion of Zhuang Yao medicinal materials, and the medicinal materials have been included in the quality standard of Zhuang Yao medicinal materials in Guangxi Zhuang Autonomous Region or approved by the drug supervision and administration department of the autonomous region;

(3) Functional indications conform to the medical theory of Zhuang Yao.

Two, one of the following varieties should be excluded.

(a) the prescription comes from the classic prescription of traditional Chinese medicine;

(two) the prescription does not have the characteristics of Zhuang medicine and other ethnic medicines;

(3) The main raw materials of the formula are chemical monomer compounds;

(4) Drugs originally developed by non-Guangxi enterprises;

(five) other circumstances that do not meet the identification of ethnic medicines.

Three, this standard shall come into force as of the date of promulgation, and the trial period is 2 years.