National Health Commission Releases Basic Standards for Traditional Chinese Medicine Clinics: TCM Treatment Rate Must Reach 100%

On December 4, the National Health and Family Planning Commission issued policies related to Traditional Chinese Medicine (TCM) clinics. The purpose is to implement the "Several Opinions of the State Council on Supporting and Promoting the Development of Traditional Chinese Medicine" (Guo Fa [2009] No. 22), strengthen the management of TCM in-clinic physician practices, and in accordance with the relevant provisions of laws and regulations such as the "Law of the People's Republic of China on Licensed Physicians" and the "Regulations on the Administration of Medical Institutions," the State Administration of Traditional Chinese Medicine and the Ministry of Health have formulated the "Administrative Measures for TCM In-Clinic Physician Practices (Trial)" and the "Basic Standards for TCM In-Clinic Physician Practices (Trial)." The "Basic Standards for TCM In-Clinic Physician Practices (Trial)" are hereby incorporated as Part V of the "Basic Standards for Medical Institutions (Trial)" (Wei Yi Fa [1994] No. 30) issued by the Ministry of Health in 1994. The Administrative Measures and Basic Standards for TCM In-Clinic Physician Practices (Trial) are now distributed to you for compliance.

Article 1 These Measures are formulated in order to strengthen the administration of traditional Chinese medicine (TCM) clinics operating within pharmacies, ensure that citizens have access to safe, effective, and convenient TCM services, and in accordance with the relevant provisions of laws and regulations such as the Law of the People's Republic of China on Licensed Physicians and the Regulations on the Administration of Medical Institutions.

Article 2 These Measures shall apply to the establishment of traditional Chinese medicine (TCM) in-pharmacy clinics by retail pharmacies.

Article 3 The National Administration of Traditional Chinese Medicine shall be responsible for the supervision and administration of TCM hall-based clinics nationwide. The health administrative departments and traditional Chinese medicine administrative departments of local people's governments at or above the county level shall be responsible for the supervision and administration of TCM hall-based clinics within their respective administrative areas.

Article 4 Retail pharmacies applying to establish traditional Chinese medicine (TCM) in-pharmacy clinics must simultaneously meet the following conditions:
(1) Possession of the "Certificate of Good Supply Practice for Pharmaceutical Products," "Pharmaceutical Operation License," and Business License;

(2) There shall be an independent business area for traditional Chinese medicine (TCM) decoction pieces, with an area of no less than 50 square meters;

(3) The quality of traditional Chinese medicine decoction pieces shall comply with national regulatory requirements, with a complete range of varieties and a quantity of no fewer than 400 types.

Article 5 The establishment of a Traditional Chinese Medicine (TCM) In-Clinic Physician Practice must comply with the healthcare institution establishment plan. The health administrative department and the TCM administration department of the local people's government at the county level shall conduct approval for establishment and practice registration in accordance with the Regulations on the Administration of Healthcare Institutions, the Detailed Rules for the Implementation of the Regulations on the Administration of Healthcare Institutions, the Basic Standards for TCM In-Clinic Physician Practices, and the relevant provisions of these Measures. The Basic Standards for TCM In-Clinic Physician Practices shall be formulated separately by the Ministry of Health and the State Administration of Traditional Chinese Medicine.

Article 6 The legal representative of a traditional Chinese medicine (TCM) in-pharmacy clinic shall be assumed by the legal representative of the retail pharmacy.

Article 7 The clinical specialties registered for a Traditional Chinese Medicine (TCM) In-Clinic Practice shall be secondary specialties under the “Department of Traditional Chinese Medicine” as listed in the Catalogue of Clinical Specialties for Medical Institutions. The number of such specialties shall not exceed two, and they shall correspond to the scope of medical services provided by the TCM In-Clinic Practice.

Article 8 The name of a TCM in-pharmacy clinic shall consist of a distinctive name and a generic name, in that order. Distinctive name: the name of the retail pharmacy and the place name; generic name: TCM in-pharmacy clinic.

Article 9 The physicians employed by a Traditional Chinese Medicine (TCM) In-Clinic Practice shall be licensed TCM practitioners who, after obtaining physician qualification and registration, have engaged in continuous clinical work at medical institutions for more than five years. A TCM In-Clinic Practice may be registered as the second practice location for a licensed TCM practitioner, provided that at least one licensed TCM practitioner has the clinic as their first practice location.

Article 10 Licensed physicians of traditional Chinese medicine (TCM) may practice in TCM clinic-within-a-pharmacy settings; licensed physicians of other categories shall not practice in such settings.

Article 11 TCM in-clinic consultation services may only provide prescription services for traditional Chinese medicine decoction pieces and shall not exceed the scope of practice; no more than two licensed TCM practitioners of the TCM category shall be on duty at the same time.

Article 12 TCM in-clinic physicians shall strictly comply with relevant national laws, regulations, rules, and technical standards; strengthen education for TCM practitioners; prevent medical malpractice; and ensure medical safety and service quality.

Article 13 Traditional Chinese Medicine (TCM) clinics operating within pharmacies shall establish and improve the following rules and regulations:
(1) Code of Professional Ethics and Conduct for Personnel;
(II) Personnel Position Responsibility System;
(3) Policies for personnel recruitment, training, management, performance evaluation, and rewards and penalties;
(4) Technical Specifications and Work Systems;
(5) Medical Malpractice Prevention and Reporting System;
(6) Medical Quality Management System;
(7) Medical Waste Management System;
(8) Patient Registration System;
(9) Financial, fee collection, archival, and information management systems;
(10) Other relevant policies and systems.
　　

Article 14 TCM in-clinic physicians’ clinics shall strictly implement the national regulations on the writing of TCM medical records and prescription management. They shall use, in strict accordance with national requirements, fee receipts uniformly printed by the relevant authorities.

Article 15 TCM in-clinic physicians’ clinics shall publicly display, in a prominent location, their approved medical specialties, diagnostic and therapeutic methods, consultation hours, fee schedules, and other relevant information.

Article 16 Medical accidents occurring in TCM clinic-based physician practices shall be handled in accordance with relevant national regulations.

Article 17 The health administrative departments and traditional Chinese medicine (TCM) administrative departments of the local people's governments at the county level shall be responsible for the routine supervision and management of TCM clinics with on-site physicians, establish and improve supervision and assessment systems, and implement systems for information disclosure as well as rewards and penalties.

Article 18 The health administrative departments and traditional Chinese medicine (TCM) administrative departments of local people's governments at the county level shall establish a system for social democratic supervision, regularly collect opinions and suggestions from citizens receiving services, and take the satisfaction of these citizens as an important criterion for evaluating TCM clinic-in-pharmacy establishments and TCM practitioners.

Article 19 Violations of the Law of the People's Republic of China on Licensed Physicians, the Regulations on the Administration of Medical Institutions and its implementing rules, as well as other laws, administrative regulations, and departmental rules, shall be penalized in accordance with relevant provisions.
　

Article 20 The health administrative departments and traditional Chinese medicine management departments of provinces, autonomous regions, and municipalities directly under the Central Government may formulate specific implementation rules in accordance with these Measures.

Article 21 These Measures shall be interpreted by the National Administration of Traditional Chinese Medicine.

Article 22 These Measures shall come into force as of the date of promulgation.

I. TCM in-house clinics shall be established by pharmacies stocking no fewer than 400 varieties of traditional Chinese medicine (TCM) decoction pieces, and are permitted to provide prescription services for TCM decoction pieces only.

II. Personnel. There shall be at least one licensed Traditional Chinese Medicine (TCM) practitioner who, after obtaining physician qualification and registration, has been continuously engaged in clinical work in a medical institution for more than five years.
　　

III. Consultation rooms must be independently partitioned, with no more than two rooms. The floor area of each consultation room shall be no less than 10 square meters.

IV. The facility is equipped with an examination table, an examination bed, an examination stool, and other equipment and facilities corresponding to the approved diagnostic and treatment specialties.

V. Establish various rules and regulations and a personnel post responsibility system; adopt medical technical operating procedures formulated or recognized by the state, compiled into a manual for practical use.