China’s Healthcare Policy and Regulation Collection February 2019
01/14/2019

China’s Healthcare Policy and Regulation Collection September 2018

1. General Office of the State Council issues the Program on Reform of Allocating Central and Local Financial Powers and Expenditure Responsibilities in Medical Treatment and HealthIn order to thoroughly implement the spirit of the 19th National Congress of the Communist Party of China and promote the implementation of the strategy “Healthy China”, according to the decisions and arrangements by the Party Central Committee and State Council on the reform of promoting allocating central and local financial powers and expenditure responsibilities, now a program on reform of allocating central and local financial powers and expenditure responsibilities in medical treatment and health is made, in accordance with the Guiding Opinions on Promoting Allocating Central and Local Financial Powers and Expenditure Responsibilities (G. F. [2016] No. 49), the “Healthy China 2030” Planning Outline, and the overall requirements of deepening reform of the medical and health system, financial powers and expenditure responsibilities in four aspects: public health, medical security, family planning, and capacity building are allocated.

2. General Office of the State Council issues the Key Tasks in the Second Half of 2018 of Deepening the Reform of the Medical and Health System: On August 28, the General Office of the State Council issued the Key Tasks in the Second Half of 2018 of Deepening the Reform of the Medical and Health System, which points out that, the key tasks in the second half of 2018 include: orderly promoting the construction of grading diagnosis and treatment system, establishing and perfecting modern hospital management system, accelerating the perfection of universal health care system, strongly promoting the construction of drug supply security system, actually strengthening the construction of comprehensive supervision system, establishing high-quality and efficient medical and health service system, and promote reforms in relevant areas as a whole.

3. National Health Commission of the People’s Republic of China and State Administration of Traditional Chinese Medicine of the People’s Republic of China issue the Opinions on Promoting the High-quality Development of Medical Service Centering on People’s HealthIn order to thoroughly implement the spirit of the 19th National Congress of the Communist Party of China, the 2nd and 3rd plenary sessions of the 19th Communist Party of China Central Committee, and the national hygiene and health conference, guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, adhering to the development idea centering on people, arousing and giving play to medical staff’s positivity and initiative, promoting the high-quality development of medical service, and securing medical safety, now they promote those opinions on development requiring strongly promoting the high-quality development of medical service, secure medial staff’s basic rights and interests according to law, creating good environment to arouse medical staff’s positivity, and enhance organizational leadership.

4. Nine ministries and commissions including National Health Commission of the People’s Republic of China, State Administration of Traditional Chinese Medicine of the People’s Republic of China, the Ministry of Public Security, and the Ministry of Commerce issue the Key Points of Special Rectification of Correcting Unhealthy Tendencies in Drug Purchase and Sales and Medical Treatment Service in 2018:In accordance with the overall requirements of the special rectification of correcting unhealthy tendencies in drug purchase and sales and medical treatment service in 2018, to thoroughly implement the spirit of the 19th National Congress of the Communist Party of China, guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, carefully implementing the spirit of the 2nd plenary session of the 19th Central Commission for Discipline Inspection, centering on the relevant arrangements about party style and incorrupt government by the Party Central Committee and State Council, thoroughly implementing the Opinions on Enhancing Party Construction in Public Hospitals, focusing on the new start point of hygiene and health cause, targeting the major current characteristics and changing trends of unhealthy tendencies in drug purchase and sales and medical treatment service, continuing the specific management of medical consumables, enhancing reasonable use of health insurance fund, strictly regulate the order in drug purchase and sales, persisting in tackling both the superficial and the essential in a balanced way, investigating both the bribe-taking and the bribe-giving to promote the improvement of the industry tendency.

5. Thirteen departments including National Administration of Traditional Chinese Medicine, State Ethnic Affairs Commission, and the National Medical Products Administration issue the Several Opinions on Enhancing Minorities’ Medicine in a New Era: On August 23, thirteen departments including NATCM, SEAC, and NMPA issued the Several Opinions on Enhancing Minorities’ Medicine in a New Era, which points out the 7 major aspects of the development of minorities’ medicine: 1. Establishment and improvement of medical service system to improve ability to prevent and treat diseases and provide services about drug affairs, promote nursing, enhance information construction, and thus really improve the medical service ability of minorities’ medicine; 2. Strong development of minorities’ medicine and life cultivation and health preservation service; 3. Actual enhancement of talents cultivation for minorities’ medicine from development of school education, and enhancement of teachings from masters to disciples and continuing education; 4. Steady promotion of inheritance and innovation of minorities’ medicine in aspects of exploring and organizing literature, systematic research, inheritance of academic thoughts and clinical experience, and research on key technology; 5. Promotion of the development of the industry of minorities’ medicine from protection, utilization, and standardized planting and breeding of medical material resources; 6. Strong promotion of minorities’ medical culture; 7. Actively promotion of the overseas development of minorities’ medicine.

6. State Administration for Market Regulation publicly solicits opinions for the Rules of Unique Identification System for Medical Equipment (Exposure Draft): On August 22, State Administration for Market Regulation publicly solicited opinions for the Rules of Unique Identification System for Medical Equipment (Exposure Draft), explicitly indicating the purpose, applicable objects, applicable scope, and principles for construction for the construction of unique identification system for medical equipment; the structure of constitution and principles of making for the unique identification for medical equipment; the form of unique identification data’s carriers and relevant requirements; the subject of liability of the unique identification database of medical equipment and requirements for data submission, etc.

7. NMPA publicly solicits opinions for the Guiding Opinions on the Construction of Drug Information Traceability System (Exposure Draft)On August 24, the NMPA publicly solicited opinions for the Guiding Opinions on the Construction of Drug Information Traceability System (Exposure Draft), which explicitly indicates the guiding disciplines for the construction of drug information traceability system and requirements for coding of drug tracing code. It is applicable to holders as well as drug operators and users for their constructing drug traceability system and to drug supervision and management authorities for their supervision and examination. The opinions are not applicable to enterprises manufacturing and operating traditional Chinese medical materials, traditional Chinese herbal pieces, bulk drug, and preparations with special packages.

8. NMPA approves the medical equipment registrant pilot work in Tianjin Municipality and Guangdong Province: On August 16, the NMPA issued the reply about approving the medical equipment registrant pilot work in Tianjin Municipality and Guangdong Province, agreeing with Tianjin’s Asking for Instructions about Pilot Work of Medical Equipment Registrant System Conducted in China (Tianjin) Pilot Free Trade Zone (J. S. C. J. G. X. Z. [2018] No. 6) and Guangdong’s Asking for Instructions about Conducting Implementation Program of Pilot Work of Medical Equipment Registrant System in Guangdong(Y. S. Y. J. J. X. [2018] No. 54).

9. CDE publicly solicits opinions for the List of Urgently Needed New Clinic Drugs in Foreign MarketOn August 8, CDE publicly solicited opinions for the List of Urgently Needed New Clinic Drugs in Foreign Market, for the drugs in this list which are not declared or is under clinic experiment in China, if the applicants considers no difference of race exists based on research, the all research materials obtained abroad and the materials supporting the absence of race difference can be submitted or supplemented, application of transaction in market can be proposed directly, and the State Drug Administration will accelerate the examination and approval according to priority examination and approval procedures. Since this day, applicants of the 48 drugs in this list can submit application of class I conference to the drug examination center according to the Regulations on Management of the Communication of Drug Research and Development and Technology Examination (Trial) to communicate matters about the declaration.

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