(Adopted at the Thirty-Sixth Meeting of the Standing Committee of the Fourth Shenzhen Municipal People’s Congress on April 2, 2010)
Chapter I General Provisions
Article 1 In order to ensure and promote the development of traditional Chinese medicine, standardize the administration of traditional Chinese medicine as a trade, and protect and improve human health, these regulations are hereby formulated in accordance with the basic principles of the related laws, regulations of the state and in the light of the actual conditions of the Shenzhen Special Economic Zone (hereinafter referred to as the Special Zone).
Article 2 The units and individuals being engaged in the activities of traditional Chinese medicine in the Special Zone shall abide by these regulations.
Article 3 The principle of combination of inheriting and innovating, coordinated development of traditional Chinese medical practice and traditional Chinese drugs shall be followed in the development of traditional Chinese medicine.
Article 4 The municipal, district governments shall insist on equal stress on traditional Chinese medicine and Western medicine, protect, direct, support, and promote the development of traditional Chinese medicine, and bring traditional Chinese medicine into the plan for national economic and social development of this jurisdiction.
Article 5 The municipal, district departments of health shall be the departments responsible for the work of traditional Chinese medicine in this administrative region and execute the following duties according to law:
(1) to implement the laws, regulations on traditional Chinese medicine, to drat the plan for the development of traditional Chinese medicine and to organize its implementation;
(2) to examine and approve the establishment of the medical institutions of traditional Chinese medicine, to issue permits for their practice, and to supervise and administer these institutions;
(3) to manage the continuing education, education by the succession of teachings from a master to disciples, health education of traditional Chinese medicine, and the exchange with foreign countries in traditional Chinese medicine;
(4) to deal with the disputes on the malpractice in traditional Chinese medicine;
(5) the other duties stipulated by laws, regulations.
Article 6 The related departments of the municipal, district governments
shall ensure and promote the development of traditional Chinese medicine in accordance with their respective duties.
Article 7 The municipal department of health shall organize and establish the expert committee of traditional Chinese medicine to execute the following duties:
(1) to organize the investigation and survey on major topics, and to make suggestions on the development of traditional Chinese medicine;
(2) to sort out, study the documentary materials of traditional Chinese medicine, and the methods, techniques of folk diagnosis and treatment of traditional Chinese medicine, and to promote the development of the theory and technology of traditional Chinese medicine;
(3) to provide professional advice for the related departments to make policies on the administration of traditional Chinese medicine.
The expert committee of traditional Chinese medicine shall consist of famous
and outstanding doctors of traditional Chinese medicine, famous and outstanding pharmacists of traditional Chinese medicine, experts recommended by the trade association, staff members of the departments of health in charge of the administration of traditional Chinese medicine, specific measures shall be formulated by the municipal department of health separately.
Article 8 The trade association of traditional Chinese medicine shall be self-disciplining organization joined by the medical institutions of traditional Chinese medicine, traditional Chinese pharmaceutical enterprises, and the specialized professionals of traditional Chinese medicine, and execute the following duties:
(1) to regulate the behaviors in the trade, and to safeguard the legitimate rights and interests of its members;
(2) to organize the academic and professional exchange in traditional Chinese medicine, propagating and popularizing of the knowledge about traditional Chinese medicine, spreading of the technologies of traditional Chinese medicine, and training of the practitioners in the trade of traditional Chinese medicine;
(3) to mediate the internal disputes in the trade;
(4) the other duties stipulated by laws, regulations, and rules.
Article 9 Efforts shall be made to strengthen the propagating, spreading, and
using of the culture and popularized scientific knowledge of traditional Chinese medicine.
October 22 of every year shall be the propagation day of traditional Chinese medicine.
Chapter II Guarantee and Promotion
Article 10 The municipal government shall establish the joint conference of the development of traditional Chinese medicine to execute the following duties:
(1) to study and draft the general and specific policies on the promotion of the development of traditional Chinese medicine;
(2) to coordinate and tackle the major problems in the development of traditional Chinese medicine;
(3) to supervise, urge, and inspect the implementation of related policies.
The joint conference of the development of traditional Chinese medicine shall
be called by the leading official of the municipal government assigned to be in charge of the work of health on a regular basis and specifically organized by the municipal department of health, and the municipal departments of development and reform, science, technology, industry, trade and information, planning and land, finance, education, public security, human resources and social security, culture, sports and tourism, market supervision and administration, drug supervision and administration, and urban management shall attend the conference.
Article 11 When the municipal, district governments and their related departments make policies concerning traditional Chinese medicine, they shall ask for advice from the expert committee of traditional Chinese medicine.
Article 12 The municipal, district governments shall support the development of traditional Chinese medicine, gradually increase financial input into traditional Chinese medicine, and give priority to the support of distinctive services of traditional Chinese medicine, infrastructure construction of the public hospitals of traditional Chinese medicine, building of key disciplines and key specialties, and training of qualified professionals in traditional Chinese medicine.
The municipal, district governments may establish the special funds of the promotion of the development of traditional Chinese medicine to be used in the basic medical treatment, teaching, scientific research of traditional Chinese medicine and the work to popularize scientific knowledge about traditional Chinese medicine.
Article 13 The municipal, district governments shall establish the mechanism to provide financial aid and compensation for the public medical institutions of traditional Chinese medicine at the municipal, district levels, and work out the measures on financial aid and compensation that are helpful in promoting the distinctive medical services of traditional Chinese medicine.
Article 14 When drafting the drug catalogue, items of diagnosis and treatment of medical insurance, the municipal department of human resources and social security shall give support to the development of traditional Chinese medicine.
When setting the rates of medical charges, the municipal department of prices shall make them to reflect the cost of services and the value of technological services of traditional Chinese medicine. The municipal department of prices shall jointly with the municipal department of health work out the items and rates of charges in accordance with the related rules of the state, Guangdong Province on the administration of prices.
Article 15 The municipal, district governments shall bring the services of traditional Chinese medicine into the projects of public medical services, support the active use of the methods and technologies of traditional Chinese medicine in the prevention and control of diseases.
The medical institutions of traditional Chinese medicine shall be encouraged to give play to the strong points of traditional Chinese medicine in health preservation and sub-healthy treatment, and to provide services in disease prevention and health preservation.
Article 16 Related departments shall treat the medical institutions of traditional Chinese medicine equally in deciding the designated medical institutions for social medical insurance, industrial injury insurance, and prophylaxis and treatment in public health emergency events.
Article 17 The related departments of the municipal, district governments shall improve the system of training and evaluating of qualified professionals of traditional Chinese medicine, and make policies which are helpful in training and evaluating qualified professionals of traditional Chinese medicine.
Article 18 The trade association of traditional Chinese medicine may, under the direction of the municipal department of health, develop the activities of appraising and electing of famous doctors of traditional Chinese medicine, famous pharmacists of traditional Chinese medicine. The municipal department of health shall jointly with the trade association of traditional Chinese medicine work out the measures on appraisal and election separately.
Article 19 The trade association of traditional Chinese medicine shall establish the honesty files and the system of early warning and public notice of honesty risks, strengthen the self-disciplining regulation of the trade; sanctions such as warning, circulating a notice of criticism within the trade, or censure may be imposed on the members who violate related laws, regulations, and rules.
Article 20 In the case of the technological appraisal of the malpractice of traditional Chinese medicine, the experts of traditional Chinese medicine shall not be less than half of the members of the expert appraisal group.
Article 21 The development of the traditional industry of traditional Chinese medicine shall be encouraged and supported. The enterprises that meet the requirements for high- and new-technology enterprises, projects, or key cultural enterprises shall enjoy the preferential policies of the development of high- and new-technology industry and cultural industry.
Article 22 The using, spreading, and protecting of classical prescriptions of traditional Chinese medicine, empirical prescriptions of traditional Chinese medicine, agreement prescriptions of traditional Chinese drugs shall be encouraged. The development of new traditional Chinese drugs shall be encouraged, and the industrialization of traditional Chinese pharmacy shall be promoted.
The qualified medical institutions of traditional Chinese medicine shall be encouraged to establish the preparation centers for traditional Chinese drugs, resources shall be used intensively, and standardized allocation shall be put into practice.
Chapter III Medical Institutions and Practitioners of Traditional Chinese Medicine
Article 23 The municipal, district governments shall bring the building of medical institutions of traditional Chinese medicine into the plans for the setup of medical institutions in their respective administrative regions, and improve the network of medical services.
Article 24 The comprehensive hospitals of traditional Chinese medicine, specialized hospitals of traditional Chinese medicine shall give first place to the services of traditional Chinese medicine, the beds of the clinical departments and sections of traditional Chinese medicine or Chinese and Western medicine in combination shall be as many as no less than 2/3 of the total beds of their hospitals respectively.
Comprehensive hospitals shall set up departments and sections of traditional Chinese medicine, the beds of the departments and sections of traditional Chinese medicine of the hospitals of the second level or higher shall be as many as no less than 5% of the total beds of their hospitals respectively.
The comprehensive hospitals of the first level and community health service institutions shall provide the services of traditional Chinese medicine. Community health service institutions shall be provided with doctors of traditional Chinese medicine.
Article 25 The following requirements shall be met to set up a clinic-house of traditional Chinese medicine, and an application shall be filed to a district department of health:
(1) to have more than 3 clinical departments and sections of traditional Chinese medicine, corresponding facilities and medical instruments;
(2) to have the independent premises of traditional Chinese pharmacy, consulting rooms, and waiting rooms that are suitable to providing medical services;
(3) the person in charge of the clinic-house of traditional Chinese medicine shall be qualified as a practicing doctor of traditional Chinese medicine and registered for practice, have more than 5 years’ clinical experience, and have obtained the technical title of physician-in-charge of traditional Chinese medicine or a higher title;
(4) to have more than 4 doctors of traditional Chinese medicine, of whom there are 1 doctor holding the title of assistant-physician-in-charge of traditional Chinese medicine or a higher title and 1 doctor holding the title of physician-in-charge of traditional Chinese medicine or a higher title respectively, and to have more than 2 nurses, 1 person of traditional Chinese pharmacy holding the title of assistant pharmacist of traditional Chinese medicine or a higher title, and at least 1 doctor of traditional Chinese medicine for each department and section;
(5) the other requirements stipulated by laws, regulations.
Article 26 If a retail drugstore meets the following requirements, it may file
an application to a district department of health for setting up a drugstore clinic with an in-house doctor of traditional Chinese medicine:
(1) to have obtained the permit for drug business and the business license to do business in the retail of herbal medicine in small pieces ready for decoction and prepared traditional Chinese drugs made by pharmaceutical companies;
(2) to have an independent consulting room suitable to providing medical services;
(3) the doctor shall be qualified as a practicing doctor of traditional Chinese medicine and registered for practice, and have more than 5 years’ clinical experience;
(4) the other requirements stipulated by laws, regulations.
Article 27 If an application meets the requirements for setting up a clinic-
house of traditional Chinese medicine, a drugstore clinic with an in-house doctor of traditional Chinese medicine, the district department of health shall approve the application and issue Approval of the Preparation of the Establishment of a Medical Institution. Approval of the Preparation of the Establishment of a Medical Institution for a clinic-house of traditional Chinese medicine shall be valid in 1 year from the date of its issuing. Approval of the Preparation of the Establishment of a Medical Institution for a drugstore clinic with an in-house doctor of traditional Chinese medicine shall be valid in 6 months from the date of its issuing.
After the preparation of the establishment of a clinic-house of traditional Chinese medicine, a drugstore clinic with an in-house doctor of traditional Chinese medicine is completed, the applicant shall apply to the district department of health for registration for practice, and may provide medical services only after obtaining Permit for Medical Institutions’ Practice according to law.
Article 28 The municipal department of health shall draft basic standards and implementation measures on the permission of the establishment of clinic-houses of traditional Chinese medicine, drugstore clinics with an in-house doctor of traditional Chinese medicine in accordance with the requirements for the establishment of such institutions stipulated in Articles 25, 26 of these regulations.
Article 29 Clinic-houses of traditional Chinese medicine, drugstore clinics with an in-house doctor of traditional Chinese medicine and their practicing doctors shall make a diagnosis and give treatment according to the items of diagnosis and treatment which are approved and registered, shall neither use Western medicine nor perform operations for treatment.
Article 30 Drugstore clinics with an in-house doctor of traditional Chinese medicine shall be the internal units of retail drugstores, the retail drugstores setting up drugstore clinics with an in-house doctor of traditional Chinese medicine shall bear legal liabilities for the activities of in-house doctors of traditional Chinese medicine in making a diagnosis and giving treatment.
Article 31 Medical institutions of traditional Chinese medicine and their practicing doctors shall comply with the requirements for the related standards of the prescriptions of traditional Chinese medicine and the dispensing of prescriptions of traditional Chinese medicine, make a diagnosis and give treatment according to conventional practice, may neither induce patients to purchase unnecessary drugs or accept unnecessary services of diagnosis and treatment, nor deceive them into doing so. Medical apparatus and instruments, health products, or other articles that have nothing to do with treatment shall not be included in prescriptions.
Article 32 Most of the employees of medical institutions of traditional Chinese medicine shall be professionals of traditional Chinese medicine, the persons in charge of departments and sections of traditional Chinese medicine shall be professionals of traditional Chinese medicine.
Article 33 Non-medical institutions shall not offer services such as naprapathy, massage, Holographic Meridian Scraping Therapy, cupping therapy, and cosmetology, etc. in the name of “treatment of traditional Chinese medicine”.
Article 34 The municipal, district departments of health shall strengthen the supervision and inspection of the medical market of traditional Chinese medicine, and set the standards for the order of the medical market of traditional Chinese medicine.
Chapter IV Traditional Chinese Drugs and Preparation
Article 35 The medical institutions offering medical treatment of traditional Chinese medicine shall provide services of traditional Chinese pharmacy, and their departments of pharmacy shall be provided with professionals specialized in traditional Chinese pharmacy. Traditional Chinese drugs shall be dispensed by professionals specialized in traditional Chinese pharmacy.
The departments of pharmacy of the medical institutions offering medical treatment of traditional Chinese medicine shall be provided with the personnel according to the following rules:
(1) the personnel in charge of traditional Chinese drugs in the departments of pharmacy of the hospitals of the third level shall be the graduates specialized in traditional Chinese pharmacy from colleges or higher-level educational institutions and hold second senior or higher professional titles in their specialty;
(2) the personnel in charge of traditional Chinese drugs in the departments of pharmacy of the hospitals of the second level shall be the graduates specialized in traditional Chinese pharmacy from junior colleges or higher-level educational institutions and hold middle-level or higher professional titles in their specialty;
(3) the personnel in charge of traditional Chinese drugs in the departments of pharmacy of the hospitals of the first level shall be the graduates specialized in traditional Chinese pharmacy from junior colleges or higher-level educational institutions and hold junior or higher professional titles in their specialty.
Article 36 The related rules on the prescription and dispensing of traditional
Chinese drugs shall be observed in the purchase, test, acceptance check, storage, processing, decoction, preparation of traditional Chinese drugs and in the prescribing and dispensing of traditional Chinese drugs.
The municipal department of drug supervision and administration shall conduct the supervision and inspection of the quality of traditional Chinese drugs in production and distribution on a regular basis.
Article 37 The medical institutions qualified for preparation may make up traditional forms of drugs out of prescribed drugs according to the requirements of the prescriptions given by doctors of traditional Chinese medicine to their patients.
Article 38 The medical institutions of traditional Chinese medicine shall be encouraged to set up the sections of traditional Chinese drug processing to process according to the standards and traditional craft of traditional Chinese drug processing the traditional Chinese herbal drugs in small pieces ready for decoction to be used in clinical practice by these institutions themselves.
Article 39 Medical institutions shall be encouraged and supported to apply for a document number of approval of preparation of traditional Chinese drugs. Doctors of traditional Chinese medicine shall be encouraged to provide for medical institutions the experience prescriptions and research prescriptions that have reliable curative effects and have been used for more than 5 years.
Article 40 The municipal, district governments shall support the building of the open laboratories of traditional Chinese drugs to provide convenience for the research and development of the new types, new forms, and new craft of traditional Chinese drugs.
Article 41 When there are emergency events of public health such as disasters, epidemics, etc., the municipal department of health may make organizational arrangements for the experts of traditional Chinese medicine to study and make plans for treatment and agreement prescriptions of traditional Chinese medicine, designate qualified medical institutions of traditional Chinese medicine to decoct traditional Chinese drugs all by themselves for patients, and may make an adjustment to the use, but must report it to the department of drug supervision and administration to be put on record within 5 days.
Chapter V Training of Professionals and Scientific Research
Article 42 The municipal, district departments of health, human resources and social security, education shall, according to the related rules of the state, improve the continuing education system for the professionals of traditional Chinese medicine, make training plans for the professionals of traditional Chinese medicine on a regular basis.
The medical institutions of traditional Chinese medicine shall, according to the related rules on the continuing education of technical professionals, make organizational arrangements for technical professionals of traditional Chinese medicine to gain continuing education, and provide necessary conditions in terms of funds and time.
The technical professionals of traditional Chinese medicine shall, according to the requirements, participate in the continuing education, and enhance the level of specialized techniques.
Article 43 The practicing doctors of traditional Chinese medicine and technical professionals of traditional Chinese pharmacy shall be encouraged to pass on their knowledge from generation to generation. The famous doctors of traditional Chinese medicine, famous traditional Chinese pharmacists shall be supported to select the clinical professionals of traditional Chinese medicine and technical professionals of traditional Chinese pharmacy of this city, pass on their academic experience and special technical skills to these professionals, and train high-level clinical professionals of traditional Chinese medicine and technical professionals of traditional Chinese pharmacy.
The municipal, district government shall provide financial aid for the work of passing on from generation to generation.
Article 44 The municipal, district governments shall give support to the systematic research in the basic theories of traditional Chinese medicine, skills of diagnosis and treatment, evaluation of curative effects, offer encouragement to unearthing and sorting out documentary materials and folk remedies of traditional Chinese medicine, promote the research and development of the new drugs of traditional Chinese medicine and medical instruments, equipment of traditional Chinese medicine, and strengthen the joint research in major diseases and the research in the prevention and treatment of common diseases, frequently-occurring diseases, and chronic diseases.
Article 45 The municipal, district governments shall pay attention to the scientific research and technological development of traditional Chinese medicine, bring them into the plan for scientific and technological development, and spread and apply the scientific and technological achievements of traditional Chinese medicine by means of financial support, government purchase of services, etc.
When examining and ratifying the projects of high and new technologies, the departments of science, technology, industry, trade and information shall give support to the scientific research projects of traditional Chinese medicine and the achievement transformation. When examining and ratifying the topics of scientific research, the departments of science, technology, industry, trade and information shall make sure that the topics of scientific research in traditional Chinese medicine should be no less than 1/10 of the all topics of medical scientific research and the experts of traditional Chinese medicine participating in the evaluation of the topics of scientific research in traditional Chinese medicine shall be no less than half of all the experts participating in the evaluation.
The departments of culture, sports and tourism shall support the projects of traditional Chinese medicine listed as immaterial cultural heritage, and bring them into the projects for building a strong cultural city.
Article 46 Efforts shall be made to develop the theory and technology of traditional Chinese medicine, apply and spread the scientific and technological achievements that have intellectual property rights, and support the products of traditional Chinese medicine that have independent intellectual property rights.
The municipal, district departments of health shall grant awards to famous prescriptions, empirical prescriptions, appropriate technologies, skills and instruments of traditional Chinese medicine, and to those who achieve breakthroughs in the study of the theory of traditional Chinese medicine and bring about social benefits of high quality.
The administration and protection of the intellectual property rights of traditional Chinese medicine shall be strengthened, and the medical institutions of traditional Chinese medicine and their employees shall be encouraged to apply for the patents of traditional Chinese medicine and the registered trademarks.
Article 47 The municipal, district governments shall support the academic exchange of traditional Chinese medicine, strengthen the direction and building of organizations such as the expert committees of traditional Chinese medicine, trade associations of traditional Chinese medicine, societies of traditional Chinese pharmacy, societies of traditional Chinese and Western medicine in combination, etc., and promote the activities such as the academic exchange, technological cooperation, scientific and technological achievement transfer, cooperation in scientific topic research, etc. in the field of traditional Chinese medicine with Hong Kong, Macao, and Taiwan, and with foreign countries as well.
Chapter VI Legal Liabilities
Article 48 In case of violation of Article 24 of these regulations, the original examining and approving department shall order corrections by a deadline, and give a warning.
Article 49 If the clinic-houses of traditional Chinese medicine, retail drugstores setting up drugstore clinics with an in-house doctor of traditional Chinese medicine, after obtaining Permit for Medical Institutions’ Practice, no longer meet the requirements for their setting up stipulated in Articles 25, 26 of these regulations and basic standards, the district departments of health shall order corrections by a deadline, if corrections have not been made after the deadline, Permit for Medical Institutions’ Practice shall be revoked.
Article 50 In case of violation of the second section of Article 27 and Article 33 of these regulations, the district departments shall order stopping practice, confiscate drugs, instruments, and illegal earnings, and impose a fine of 20,000 RMB; as for those retail drugstores having obtained Permit for Drug Business, the departments of drug supervision and administration shall revoke their Permit for Drug Business.
Article 51 If the clinic-houses of traditional Chinese medicine, retail drugstores setting up drugstore clinics with an in-house doctor of traditional Chinese medicine violate Article 29 of these regulations, the district departments of health shall order corrections by a deadline, confiscate drugs, instruments, and illegal earnings, and impose a fine of 20,000 RMB; if corrections have not been made after the deadline, Permit for Medical Institutions’ Practice shall be revoked, as for the retail drugstores having obtained Permit for Drug Business, the departments of drug supervision and administration shall revoke their Permit for Drug Business; if a crime is constituted, the criminal responsibility shall be investigated and ascertained.
If practicing doctors violate Article 29 of these regulations, the district departments of health shall order corrections by a deadline and give a warning; if corrections have not been made after the deadline, their practice shall be suspended for 1 year; if circumstances are serious, their licenses for doctors’ practice shall be revoked; if a crime is constituted, the criminal responsibility shall be investigated and ascertained.
Article 52 If the medical institutions of traditional Chinese medicine and their practicing doctors violate Article 31 of these regulations, the departments of health shall order corrections and give a warning; if corrections have not been made after the deadline, a fine of 5,000 RMB shall imposed on a medical institution, a fine of 3,000 RMB shall be imposed on a doctor; if the circumstances are serious, they shall be ordered to suspend practice for 3 months respectively.
Article 53 In case of violation of Articles 32, 35 of these regulations by providing unqualified professionals of traditional Chinese medicine, the departments of health shall order corrections by a deadline; if corrections have not been made after the deadline, a fine of 50,000 RMB shall be imposed.
Article 54 If the municipal, district departments of health and their personnel violate these regulations in the administration of traditional Chinese medicine, fail to execute their administrative duties, abuse power, and practice favoritism and commit irregularities, administrative sanctions shall be imposed on them; if a crime is constituted, the criminal responsibility shall be investigated and ascertained.
Chapter VII Supplementary Provisions
Article 55 The following terms used in these regulations shall mean as follows:
(1) traditional Chinese medicine means traditional Chinese medicine, traditional Chinese medicine and Western medicine in combination, national medicine, and traditional Chinese drugs, national drugs;
(2) the medical institutions of traditional Chinese medicine mean hospitals and outpatient departments of traditional Chinese medicine, traditional Chinese medicine and Western medicine in combination, and national medicine, clinic-houses and clinics of traditional Chinese medicine, drugstore clinics with an in-house doctor of traditional Chinese medicine;
(3) the traditional forms of drugs mean decoction, pills, powder, medicinal extract, sublimed preparation, vinum, medicinal tea, pastille, medicinal jelly, distillate medicinal water, medicated roll, thread formula, moxibustion, herbal leaven, etc.
Article 56 If these regulations stipulate that specific implementation
measures shall be formulated, the municipal government and related departments shall worked them out within 6 months from the date when these regulations take effect.
Article 57 These regulations shall take effect as of July 1, 2010.
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