February 9，Several Opinions on the "Several Opinions on Further Reform and improve and improve the use of drug production circulation and use policies" were held before the Spring Festival. "。"Several Opinions" involves drug production、circulation、Use each link，Known as a full chain in the pharmaceutical field、Major reform policy of the whole process。The following is the full text of "Several Opinions":
General Office of the State Council about further reform and improvement of medicines
Several opinions of the production and circulation policy
National Office [2017] No. 13
Each province、Autonomous Region、The People's Government of the Municipal Government，All Ministries and Commissions of the State Council、Direct institutions:
To deepen the reform of the medical and health system，Improve the quality of drug quality，Standardized drug circulation and use behavior，better meet the needs of the people to see a doctor for medical treatment，Promote the construction of healthy China，Agree with the State Council，Now put forward the following opinions on further reform and improvement of drug production and circulation:
1、Improve the quality of drug quality，Promoting the adjustment of the pharmaceutical industry structure
(1) Strict drug listing review approval。New drug review highlights clinical value。Imitation drug review is strictly based on the principle of the quality and efficacy of the original drug。Enjoy the review power，Strengthen the guidance of the research and development of enterprises，Establish an effective communication and exchange mechanism with applicants，Accelerate the backlog of drug registration application。Optimized drug review approval procedures，New drugs and shortage drugs that are urgently needed clinically needed to accelerate review and approval。Drawing on international advanced experience，Explore by rare disease、Children、Elderly、Urgent (grab) category review and approval of categories such as rescue drugs and Chinese medicine (classic prescription)，Guarantee children、Demand for the prevention and treatment of major diseases and major illnesses for the elderly。Patented drugs required for major illnesses，For compulsory licenses when necessary。Strengthen clinical trial data verification，Severe punishment of data counterfeit behavior。Comprehensive public drug review approval information，Strengthen social supervision。
(2) Accelerate the assessment of the consistency of the quality and efficacy of imitation drugs in the market。Encourage pharmaceutical manufacturers to actively purchase the governing preparations in accordance with relevant guidance principles，Reasonable selection of evaluation methods，Carry out research and evaluation。Reference preparations that need to be imported，Accelerate import approval，Improve customs clearance efficiency。Implementation of record system for biological equivalent test，Allowing conditional medical institutions、High school、Scientific research institutions and other social office inspection and testing agencies conduct consistency evaluation of biological equivalent tests，Implementation measures will be formulated separately。Food and Drug Supervision and other departments should strengthen guidance to enterprises，Promote the consistency evaluation work task to complete on time。Drugs that pass the consistency evaluation，Relevant information to the society in time，and incorporate it into the directory of the drug with the original drug。Production enterprises with consistency evaluation through the same variety of medicines，No longer selected varieties that have not passed consistency evaluation in centralized procurement of drugs; not more than 3，Priority procurement and use varieties that have passed consistency evaluations。Accelerate the formulation of medical insurance payment standards in accordance with the general name，Incentive My stake betting appmechanisms that are conducive to the use of imitation drugs through consistency evaluation as soon as possible。
(3) Piloting the system for promotion of drug listing permits in an orderly manner。Priority to the new drug approved for listing and the pilot holder system for pilot evaluation of consistency evaluation，Encourage new drug research and development，Promoting new products、New technology and existing capacity docking。Timely summarizing the pilot experience，Improve relevant policy measures，Strive to push away in the country as soon as possible。
(4) Strengthen the quality and safety supervision of drug production。Urgent enterprises to strictly implement drug production quality management specifications (GMP)，Record all information of the production process，Make sure the data is true、Full、Accurate、traceable。Strengthen the supervision and inspection of the implementation of the quality management of enterprise drug production，The results of the inspection were announced to the public，and take measures to control risks in time。Change of enterprises to drug raw materials、Production process adjustment, etc.，Full verification should be performed。Strictly cracking down on illegal behaviors of fake and inferior drugs。
(5) Increase adjustment of the pharmaceutical industry structure。Strengthen technological innovation，Implementation of major national science and technology plans such as creating major new drugs creation technology (special、Fund, etc.)，New drugs and key technologies developed by eligible enterprises and research institutes，Improve drug innovation ability and quality efficacy。Promote the exit of backward enterprises，For the number of drug production enterprises, the number of drug production enterprises is more、Small scale、Low levels and other questions。Support drug production enterprise merger and reorganization，Simplify the approval procedures for the listing license of the transfer of products across the group，Cultivate a group of large enterprise groups with international competitiveness，Improve the concentration of the pharmaceutical industry。Guide to have a brand、Technology、Small and medium -sized enterprises with characteristic resources and management advantages are better and stronger in various ways such as industrial alliances。Improve the level of intensive production，Promote the formation of a number of brand medicines with high clinical value and high quality level。
(6) Guarantee effective supply of drugs。Health and planning、Industry and Information Technology、Business、Food and Drug Supervision and other departments must cooperate closely，Improve shortage of drugs、Low -priced drug monitoring and early warning and hierarchical response mechanism，Establish and improve shortage of drug information collection、Submit、Analysis、The business system，Dynamic mastery of key enterprises production conditions，Organize fixed -point production、Drug Reserve、Emergency production、Consultation adjustment and other measures to ensure the supply of the drug market。Take the registration commitment、Drug price negotiation、Concentrated purchase、Comprehensive measures such as medical insurance payment，Promoting the realization of patented drugs and the marketing price of patented drugs in my country is not higher than the native country or around my country，and implement dynamic management。Strengthen the management of anesthesia and psychiatric drugs。Support quality reliable、The use of accurate medical institutions Chinese medicine preparation specifications。
2、Rectifying the order of drug circulation，Promoting the reform of the drug circulation system
(7) Promoting the transformation and upgrading of drug circulation enterprises。Breaking the market segmentation of the pharmaceutical products、Local protection，Promoting drug circulation enterprises across the region、Cross -ownership mergers and reorganization，Cultivation of the backbone of large modern drug circulation。Integrated drug storage and transportation resources，Realize multi -warehouse collaboration，Support drug circulation enterprise cross -regional distribution，Accelerate the formation of large -scale backbone enterprises as the main body、Small and medium -sized enterprises supplemented by urban and rural drug circulation networks。Encourage the professional operation of small and medium -sized drug circulation enterprises，Promote some enterprises to transform to distribution distribution mode。Encourage drug circulation enterprises to wholesale and retail integrated operation。Promoting retail pharmacies graded classification management，Improve the retail chain rate。Encourage drug circulation enterprises to participate in the construction of international drug procurement and marketing networks。
stake sports betting app(8) Promote the purchase and sale of drugs & ldquo; two votes & rdquo;。Comprehensive medical reform pilot province (district、City) and the pilot cities of the reform of public hospitals must take the lead in implementing & ldquo; two -vote & rdquo;，Encourage other regions to implement & ldquo; two votes & rdquo;，Strive to push open in the country in 2018。Drug circulation enterprise、Medical institutions to purchase and sell drugs must establish a complete information purchase and sell records，Do the bill、Account、Cargo、The payment is consistent，Seding with the cargo and medicine。Enterprise sales drugs shall issue invoices and sales vouchers。Actively promote the standardization of drug purchase and selling bills、Electronic。
(9) Improve the drug procurement mechanism。Implementing drug classification procurement policy，Public transparency、Principles of fair competition，Scientific setting review factors，Further increase the participation of medical institutions in centralized procurement of drugs。Encourage cross -regional and specialist hospitals to jointly purchase。Areas in which the reform of medical insurance payment methods is comprehensively implemented or the standards of medical insurance payment standards have been formulated，Allows public hospitals to jointly band on the provincial -level drug centralized procurement platform (provincial public resource trading platform)、Budget purchase。Improve the state drug price negotiation mechanism，Gradually expand the range of negotiating varieties，Do a good job of connecting policies such as medical insurance。Strengthen the standardization of national drug supply guarantee comprehensive management information platform and provincial drug centralized procurement platform，Improve the pharmaceutical procurement data sharing mechanism。
(10) Strengthen the management of drug purchase and selling contracts。Health and planning、Business and other departments must formulate a model for purchasing and selling contracts，Supervise the purchase and marketing parties to sign the contract according to law and strictly perform。Drug Production、Circulation enterprises must fulfill social responsibility，Guaranteed drugs to produce timely、Delivery，Medical institutions and other purchases should settle the payment in time。For violating the contract agreement，Delivery does not timely affect clinical medication or refuses to provide providing providing remote areas of distribution services，Provincial pharmaceutical procurement institutions shall urge its rectification within a time limit;，Cancel the winning qualification，Remember to record bad records of drug procurement and announce to the society，Public hospitals must not purchase their medicines within 2 years。For violating the contract agreement，Medical institutions that do not repay the payment on schedule or extend the payment cycle in disguise，The health and family planning department must correctly corrected and notified criticism，Credit records in enterprises and institutions。Put the drugs on time as the annual assessment of the public hospital and the annual end of the president。
(11) Rectify prominent problems in the field of drug circulation。Food and Drug Supervision、Health and planning、Human Resources and Social Security、Price、Tax、Industry and Commerce、Public security and other departments must jointly carry out special inspections，Strict crackdown on the rental license、false transactions、Forge records、illegal channel purchase and selling medicine、Commercial bribery、Price fraud、Price monopoly and forgery、Victoring invoices and other violations of laws and regulations，Carefully punish illegal illegal enterprises and medical institutions，serious accountability of the relevant person in charge;，Timely transfer to judicial organs for processing。Improve relevant laws and regulations，illegal and illegal acts that have been verified，Remembering Pharmaceutical Purchase Bad Record、Credit records and personal credit records of enterprises and institutions and disclose it in accordance with regulations，Public hospitals shall not purchase relevant enterprise drugs within 2 years;，Further increase the punishment intensity，Improve the cost of violations and regulations。Implementation measures will be formulated separately。Food and Drug Supervision Department must strengthen the management of medical representatives，Establishing a medical representative registration filing system，Record information disclosure in time。Medical representatives can only engage in academic promotion、Technical Consultation and other activities，Do not bear the drug sales task，It is recorded in personal credit records for their dishonesty。
(12) Strengthen price information monitoring。Improve the drug price monitoring system，Promote the transparent information stake online sports bettingof the drug market price。Food and Drug Supervision Department leads to start establishing a pharmaceutical ex -factory price information information traceability mechanism，Establish a unified cross -departmental price information platform，Do a good job of centralized procurement platform (public resource trading platform)、The interconnection of the medical insurance payment audit platform，Strengthen the sharing of relevant tax data。Pharmaceutical manufacturers who falsely reported raw materials and pharmaceuticals from drugs，Price、Food and Drug Supervision、Taxation and other departments must investigate and deal with it seriously in accordance with the law，Clear tax receivable，Hold the person in charge of the responsible person。The price of the factory (port) that strengthens the drug inadequate drugs、Actual purchase and sale price monitoring，Drugs with abnormal price changes or drugs with too much price difference with the same variety，Research and analysis in time，Special survey of cost price when necessary。
(13) Promote & ldquo; Internet+drug circulation & rdquo;。Cenisty to meet the needs of the masses' safety and convenience，Actively play & ldquo; Internet+drug circulation & rdquo;、Improve circulation efficiency、Promoting information disclosure、Breaking the advantages and functions of monopoly。Guide & ldquo; Internet+drug circulation & rdquo; specification development，Support drug circulation enterprises and Internet companies to strengthen cooperation，Promote online and offline integration development，Cultivate emerging formats。Standardize the Internet retail service of retail pharmacy，Promotion & ldquo; Online booking store & rdquo;、& ldquo; The new type of distribution method of giving & rdquo;。Encourage conditional areas to rely on existing information systems，Carry out the online prescription review of pharmacists、Reasonable medication guidance and other pharmaceutical services。Food and Drug Supervision、Business and other departments should establish and improve the management system of Internet drug trading，Strengthen daily supervision。
3、Standardized medical and medication behavior，Reform adjustment interest drive mechanism
(14) Promote reasonable medication。Optimized adjustment Basic drug directory。Public hospitals must be fully equipped、Prefer to use basic drugs。The National Health and Family Planning Commission shall organize the comprehensive evaluation of clinical drugs，Explore the evaluation results as centralized procurement of drugs、Estimated to formulate a guide for clinical medication。Expand the clinical path coverage，Achieved a comprehensive clinical path management of hospitals above the end of 2020。Medical institutions should use drug procurement as an important content for public affairs，Public drug price every quarter、Dosage、Drug ratio and other information; implement the prescription review、Regulations on the treatment of syndrome differentiation of Chinese medicine，Key monitoring antibiotics、Auxiliary medicine、Use of nutritional drugs，Public announcement of prescription doctors with unreasonable medication，Create an interview system。Strict management of temporary procurement drugs。The health and family planning department shall evaluate the rational use of the medical institutions，Assessment results with Dean Rating、Performance salary verification and other hooks，Specific rules will be formulated separately。
(15) further break the medicine supplementation mechanism。Persist in medical treatment、Medical Insurance、Medicine linkage，Coordinated Promoting Cancel Drug Bonus、Adjust the price of medical services、Encourage reforms such as retail pharmacies to buy drugs and other reforms，Implementing government input responsibility，Accelerate the establishment of a new mechanism for compensation for public hospitals。Promote the separation of medicine。Medical institutions should be prescribed according to the common name of the drug，and actively provide a prescription to the patient。Patients with outpatients can choose to buy medicine at medical institutions or retail pharmacies，Medical institutions shall not restrict outpatient patients to buy medicine at retail pharmacies with prescriptions。Conditional Explorer the outpatient pharmacy from the medical institution to be separated from the medical institution。Explore the prescription information of medical institutions、Medical Insurance Settlement Information and Drug Retail Consumption Information Interconnection、Real -time sharing。Health and family planning and other departments at all levels must combine actual，Reasonable determination and quantitative regional medical expenses growth rate，and implement it to medical institutions，My stake betting appStrictly control the unreasonable growth of medical expenses。Regularly rank medical expenses in various places，and announce to the society，Actively accept supervision。The control of medical expenses with the financial subsidy of public hospitals、Evaluate the best、Performance salary verification、Dean's evaluation and hook，Hospital for failing to reach the target of the fee control，Specify its grade review access、New bed approval and large equipment equipment，Disum or cancel funds subsidy as the situation、Project arrangement，and investigate the corresponding management responsibility of the hospital's dean。
(16) The role of strengthening medical insurance standards and control costs。Give full play to various medical insurance for medical services、Control and supervision and restriction of medical expenses，Gradually extended the supervision of medical insurance to medical institutions to the supervision of medical service behavior in medical staff。Exploring the establishment of a medical insurance institution credit rating management and blacklist management system。Timely revising the medical insurance and drug directory。Strengthen the Budget Management of the Medical Insurance Fund，Vigorously promote the reform of medical insurance payment methods，Comprehensive implementation of paying according to diseases，Pay at the first person、Compound payment methods combined with a variety of payment methods such as daily payment by bed，Reasonable determination of medical insurance payment standards，Pharmaceutical consumables、Inspection and laboratory changes from medical institutions to cost，Promote the active regulating medical behavior of medical institutions、Reduce operating costs。
(17) Actively give play to the role of pharmacist。Implementing pharmacist's rights and responsibilities，Give full play to the role of the pharmacist in reasonable medication。When promoting the reform of medical services in various places，Prescription review and adjustment of prescriptions carried out by pharmacists、Clinical medication guidance、Standardized medication and other work，To consider the actual coordination，Explore reasonable compensation path，and do a good job of connecting policies such as medical insurance。Strengthening the training of retail pharmacies，Improve pharmaceutical service capabilities and levels。Accelerate the legislative process of pharmacist law。Explore the pharmacist multi -point practice。Reasonable planning and allocation of pharmaceutical talent resources，Strengthening digital identity management，Strengthen the construction of the pharmacist team。
Reform of drug production and circulation involves the main body of interests，The safety of medication for the people，The healthy development of the pharmaceutical industry，Reason for social harmony and stability。All places、Each department must fully understand the importance of reform、urgency and arduousness，Invest more energy to grasp the implementation of reform。To strengthen organizational leadership，Combining actual refine work plan and supporting rules，Improve the mechanism and method of implementing the implementation，Pressing responsibility、Requirements to be implemented、Assessment Gobies，Enhance the fixed force of reform，Active and steadily advance，Ensure that reform measures come into effect。To evaluate and summarize the progress of the work in time，Research solve the new situation、New Questions，Constantly improve the system of drug supply guarantee。To strengthen policy interpretation and public opinion guidance，Timely response to social concerns，Actively create a good atmosphere of public opinion。
General Office of the State Council
January 24, 2017
