Accelerate the evaluation of quality and efficacy of generic drugs

[policies and regulations of chinapharma.com] the general office of the State Council has recently triggered several opinions on further reform and improvement of the policies for the production, circulation and use of drugs, among which the focus is on accelerating the consistency evaluation of the quality and efficacy of the generic drugs on the market According to the opinions, pharmaceutical manufacturers are encouraged to actively select reference preparations, reasonably select evaluation methods, and carry out research and evaluation according to relevant guiding principles For reference preparations that need to be imported, the import examination and approval shall be accelerated to improve the efficiency of customs clearance The bioequivalence test shall be managed by filing system, and the qualified medical institutions, institutions of higher learning, scientific research institutions and other social inspection and testing institutions shall be allowed to carry out the bioequivalence test of conformity assessment according to law The implementation measures shall be formulated separately Food and drug supervision and other departments should strengthen the guidance of enterprises and promote the completion of consistency evaluation tasks on schedule For the drugs passing the consistency evaluation, relevant information shall be released to the society in time and included in the list of drugs that can be replaced by the original drugs If there are more than three manufacturers that have passed the consistency evaluation of the same kind of drugs, they will no longer choose the varieties that have not passed the consistency evaluation in terms of centralized purchase of drugs; if there are less than three manufacturers, they will give priority to purchase and use the varieties that have passed the consistency evaluation We will speed up the formulation of payment standards for medical insurance drugs under the common name, and form an incentive mechanism as soon as possible that is conducive to the consistent evaluation of the use of generic drugs The details are as follows: Several Opinions of the general office of the State Council on further reform and improvement of drug production, circulation and use policies (GBF [2017] No 13) people's governments of all provinces, autonomous regions and municipalities directly under the central government, ministries and commissions of the State Council, and organizations directly under the State Council: In order to deepen the reform of the medical and health system, improve the quality and efficacy of drugs, standardize the circulation and use of drugs, better meet the people's medical needs, and promote the construction of a healthy China, with the consent of the State Council, the following opinions are put forward on further reform and improvement of the relevant policies for the production, circulation and use of drugs: 1 Improve the quality and efficacy of drugs and promote the structural adjustment of the pharmaceutical industry (1) strictly review and approve the listing of drugs New drug evaluation highlights clinical value The generic drug evaluation shall be carried out in strict accordance with the principle of consistency with the quality and efficacy of the original research drug We should strengthen the evaluation force, strengthen the guidance of enterprise R & D, establish an effective communication mechanism with applicants in advance, and speed up the solution to the backlog of drug registration applications We will optimize the procedures for drug review and approval, and accelerate the review and approval of new drugs and drugs in short supply that are urgently needed in clinical practice Learn from international advanced experience, explore the classification review and approval according to rare diseases, children, the elderly, emergency (rescue) drugs and traditional Chinese medicine (classic formula), so as to ensure the needs of children, the elderly and other groups and major diseases When necessary, compulsory licensing may be implemented according to law for drugs needed for the prevention and control of major diseases We will strengthen the verification of clinical trial data and severely punish data fraud We will make drug review and approval information public in an all-round way and strengthen social supervision 2 Accelerate the evaluation of the consistency of the quality and efficacy of the generic drugs on the market Drug manufacturers are encouraged to actively purchase reference preparations according to relevant guidelines, reasonably select evaluation methods, and carry out research and evaluation For reference preparations that need to be imported, the import examination and approval shall be accelerated to improve the efficiency of customs clearance The bioequivalence test shall be managed by filing system, and the qualified medical institutions, institutions of higher learning, scientific research institutions and other social inspection and testing institutions shall be allowed to carry out the bioequivalence test of conformity assessment according to law The implementation measures shall be formulated separately Food and drug supervision and other departments should strengthen the guidance of enterprises and promote the completion of consistency evaluation tasks on schedule For the drugs passing the consistency evaluation, relevant information shall be released to the society in time and included in the list of drugs that can be replaced by the original drugs If there are more than three manufacturers that have passed the consistency evaluation of the same kind of drugs, they will no longer choose the varieties that have not passed the consistency evaluation in terms of centralized purchase of drugs; if there are less than three manufacturers, they will give priority to purchase and use the varieties that have passed the consistency evaluation We will speed up the formulation of payment standards for medical insurance drugs under the common name, and form an incentive mechanism as soon as possible that is conducive to the consistent evaluation of the use of generic drugs (3) to orderly promote the pilot of the drug listing license holder system Priority shall be given to the trial implementation of the new drugs approved for listing and the drugs passing the consistency evaluation of the listing license holder system, to encourage the research and development of new drugs, and to promote the docking of new products, new technologies and existing production capacity Summarize the pilot experience in a timely manner, improve relevant policies and measures, and strive to push forward in the whole country as soon as possible (4) to strengthen the supervision of drug production quality and safety Supervise and urge the enterprise to strictly implement the GMP, record all information in the production process truthfully, and ensure that the data is true, complete, accurate and traceable Strengthen the supervision and inspection of the implementation of the drug production quality management standards of enterprises, publicize the inspection results to the society, and take measures to control risks in time The enterprise shall fully verify the change of raw and auxiliary materials and the adjustment of production process We will severely crack down on the illegal and criminal acts of manufacturing and selling fake and substandard drugs (5) to strengthen the structural adjustment of the pharmaceutical industry We will strengthen technological innovation, implement national science and technology plans (special projects, funds, etc.) such as major science and technology projects for major new drug creation, support qualified enterprises and scientific research institutes to develop new drugs and key technologies, and improve drug innovation capacity and quality and efficacy We will promote the withdrawal of backward enterprises, and strive to resolve the problems of large number, small scale and low level of pharmaceutical manufacturers We will support the merger and reorganization of pharmaceutical manufacturing enterprises, simplify the approval procedures for the listing permission of cross regional transfer products within the group, foster a number of large-scale enterprise groups with international competitiveness, and improve the concentration of the pharmaceutical industry We will guide small and medium-sized enterprises with advantages in brand, technology, characteristic resources and management to become better and stronger by means of industrial alliance To improve the intensive production level and promote the formation of a batch of brand drugs with high clinical value and quality level (6) ensuring the effective supply of drugs Health and family planning, industry and information technology, commerce, food and drug supervision and other departments should work closely together to improve the monitoring, early warning and hierarchical response mechanism of short drugs and low-cost drugs, establish and improve the information collection, submission, analysis and consultation system of short drugs, dynamically grasp the production situation of key enterprises, and take measures such as fixed-point production, drug storage, emergency production, consultation and coordination as a whole Ensure the supply of drugs in the market Take comprehensive measures such as registration commitment, drug price negotiation, centralized procurement, medical insurance payment, etc to promote the realization that the marketing price of drugs and expired drugs in China is not higher than the comparable price in the country of origin or around China, and implement dynamic management We will strengthen the management of narcotic drugs and psychotropic substances To support the standardized use of traditional Chinese medicine preparations in medical institutions with reliable quality and definite curative effect 2 Rectify the order of drug circulation, promote the reform of drug circulation system (7) promote the transformation and upgrading of drug circulation enterprises Break the market segmentation and local protection of pharmaceutical products, promote the cross regional and cross ownership merger and reorganization of pharmaceutical distribution enterprises, and cultivate large-scale modern pharmaceutical distribution backbone enterprises We will integrate drug storage and transportation resources, achieve multi warehouse coordination, support cross regional distribution of drug distribution enterprises, and accelerate the formation of urban and rural drug distribution networks with large-scale backbone enterprises as the main body and small and medium-sized enterprises as the supplement We will encourage small and medium-sized drug distribution enterprises to engage in specialized operations, and promote the transformation of some enterprises into distribution and distribution models We will encourage integrated wholesale and retail operations of drug distribution enterprises Promote the classified management of retail pharmacies and improve the retail chain rate Encourage drug distribution enterprises to participate in the construction of international drug procurement and marketing network (8) to promote the "two ticket system" for the purchase and sale of drugs Comprehensive medical reform pilot provinces (districts, cities) and public hospital reform pilot cities should implement the "two vote system", encourage other regions to implement the "two vote system", and strive to push it across the country by 2018 Drug distribution enterprises and medical institutions shall establish complete purchase and sale records to ensure that bills, accounts, goods and payments are consistent with each other, and they shall go with the drugs along with the bills of the same trade Enterprises selling drugs shall issue invoices and sales vouchers in accordance with regulations Actively promote standardized and electronic management of drug purchase and sale bills (9) improve the drug purchase mechanism In order to further improve the participation of medical institutions in the centralized procurement of drugs, we should implement the policy of classified procurement of drugs, scientifically set up evaluation factors in accordance with the principles of openness, transparency and fair competition Encourage cross regional and specialized hospital joint procurement In areas where the reform of medical insurance payment method has been fully implemented or medical insurance drug payment standards have been formulated, public hospitals are allowed to jointly purchase drugs with quantity and budget on the provincial drug centralized purchase platform (provincial public resource trading platform) We will improve the national drug price negotiation mechanism, gradually expand the scope of negotiation varieties, and better link up with policies such as medical insurance We will strengthen the standardized construction of the national drug supply security comprehensive management information platform and the provincial drug centralized procurement platform, and improve the data sharing mechanism for drug procurement (10) strengthen the management of drug purchase and sale contracts Health and family planning, business and other departments shall formulate model purchase and sale contracts, and urge both parties to sign contracts and strictly perform them according to law Drug production and distribution enterprises shall fulfill their social responsibilities, ensure the timely production and distribution of drugs, and medical institutions and other purchasers shall timely settle the payment for goods For the enterprises that violate the contract, fail to timely affect clinical medication or refuse to provide delivery service in remote areas, the provincial drug purchasing agency shall urge them to rectify within a time limit; if they fail to rectify within the time limit, they shall be disqualified from winning the bid, recorded in the bad records of drug purchase and announced to the society, and the public hospital shall not purchase their drugs within two years For the medical institutions that violate the contract, fail to collect the payment on time or extend the payment period in disguised form without justified reasons, the health and family planning department shall correct them in time, criticize them in a notice and record them in the credit records of enterprises and institutions The regular payment collection of drugs is an important part of the annual evaluation of public hospitals and the year-end evaluation of presidents (11) to rectify outstanding problems in the field of drug circulation Food and drug supervision, health and family planning, human resources and social security, price, tax, industrial and commercial administration, public security and other departments should carry out regular joint special inspections, severely crack down on illegal behaviors such as leasing licenses, false transactions, forgery of records, purchase and sale of drugs through illegal channels, commercial bribery, price fraud, price monopoly, forgery and false Invoicing, and severely punish illegal behaviors according to law Enterprises and medical institutions that violate the rules shall be investigated for the responsibility of relevant persons in charge; those suspected of crimes shall be transferred to the judicial organ for handling in time Improve the relevant laws and regulations, record the verified illegal behaviors into the bad drug purchase records, the credit records of enterprises and institutions and personal credit records, and make them public according to the regulations Public hospitals are not allowed to purchase the relevant enterprise drugs within two years; for recidivists or serious cases, further increase the punishment according to the law, and increase the cost of illegal behaviors The implementation measures shall be formulated separately The food and drug regulatory authorities shall strengthen the management of medical representatives, establish a registration and filing system for medical representatives, and disclose the filing information in a timely manner Medical representatives can only engage in academic promotion, technical consultation and other activities, and shall not undertake the task of drug sales Their dishonesty shall be recorded in personal credit records (12) strengthening price