| pinions of the State Council on Reform of the System of Evaluation, Review and Approval of Drugs and Medical Devices | | 国务院关于改革药品医疗器械审评审批制度的意见 |
| (No. 44 [2015] Issued by the State Council) | | （国发〔2015〕44号） |
| The People's Governments of all provinces, autonomous regions and municipalities directly under the Central Government; the ministries and commissions under the State Council; and the institutions directly affiliated to the State Council: | | 各省、自治区、直辖市人民政府，国务院各部委、各直属机构： |
| Over recent years, China's pharmaceutical industry has developed rapidly, with both the quality and standards of drugs and medical devices keeping improving, relatively well meeting public demand for use of drugs. Meanwhile, problems existing in evaluation, review and approval of drugs and medical devices have also become increasingly outstanding, with the quality of application documentation for registration not high, and with the process of review and approval in need of supplementation and improvement thereof many times, which seriously impacts the efficiency of evaluation, review and approval. There are overlapping construction and overlapping application with respect to generic drugs, with cutthroat market competition, and with the existence of relatively big differences between the quality of some generic drugs and advanced world levels. The time for review and approval for market supply of new drugs which are badly needed clinically is excessively long, and drug research and development institutions and scientific and technological research personnel cannot apply for registration of drugs, which negatively impacts the enthusiasm for innovation of drugs. Therefore, the following Opinions on reform of the system of evaluation, review and approval of drugs and medical devices are hereby raised: | | 近年来，我国医药产业快速发展，药品医疗器械质量和标准不断提高，较好地满足了公众用药需要。与此同时，药品医疗器械审评审批中存在的问题也日益突出，注册申请资料质量不高，审评过程中需要多次补充完善，严重影响审评审批效率；仿制药重复建设、重复申请，市场恶性竞争，部分仿制药质量与国际先进水平存在较大差距；临床急需新药的上市审批时间过长，药品研发机构和科研人员不能申请药品注册，影响药品创新的积极性。为此，现就改革药品医疗器械审评审批制度提出以下意见： |
| I. Major Objectives | | 一、主要目标 |
| 1. Improvement of the quality of evaluation, review and approval: A more scientific and efficient system of evaluation, review and approval of drugs and medical devices shall be established, in order that the validity, safety and quality controllability of drugs and medical devices that have been approved for market supply will reach or get close to advanced world levels. | | （一）提高审评审批质量。建立更加科学、高效的药品医疗器械审评审批体系，使批准上市药品医疗器械的有效性、安全性、质量可控性达到或接近国际先进水平。 |
| 2. Settlement of the backlog of applications for registration: Review and approval of drugs that are oversupplied at the marketplace shall be brought under strict control. Disposal of the existing backlog by the end of 2016 shall be striven for. Annual balance between the acceptance of applications for registration and the quantity of review and evaluation thereof shall be realized as early as possible. Review and approval by the prescribed time limit shall be realized in 2018. | | （二）解决注册申请积压。严格控制市场供大于求药品的审批。争取2016年底前消化完积压存量，尽快实现注册申请和审评数量年度进出平衡，2018年实现按规定时限审批。 |
| 3. Improvement of the quality of generic drugs: Conformity evaluation of the quality of generic drugs shall be accelerated, and completion of conformity evaluation of oral preparations and reference preparations of national basic drugs by the end of 2018 shall be striven for. | | （三）提高仿制药质量。加快仿制药质量一致性评价，力争2018年底前完成国家基本药物口服制剂与参比制剂质量一致性评价。 |
| 4. Encouragement of research for and creation of new drugs: Innovation of drugs oriented toward clinical value shall be encouraged, and the procedure for review, evaluation and approval of innovative drugs shall be improved, with acceleration of review and evaluation of innovative drugs that are imperatively needed clinically. Pilot projects of experiment on the system of holders of the license for marketing of drugs shall be launched. | | （四）鼓励研究和创制新药。鼓励以临床价值为导向的药物创新，优化创新药的审评审批程序，对临床急需的创新药加快审评。开展药品上市许可持有人制度试点。 |
| 5. Increase of transparency of review, evaluation and approval: The conditions and the relevant technical requirements for acceptance and processing of applications for registration of drugs and medical devices, technical review thereof, product inspection and on-site inspection shall be made public on a full scale. The relevant information on acceptance and processing, and review and approval shall be disclosed. Applicants shall be guided to conduct research and development and make applications in an orderly way. | | （五）提高审评审批透明度。全面公开药品医疗器械注册的受理、技术审评、产品检验和现场检查条件与相关技术要求，公开受理和审批的相关信息，引导申请人有序研发和申请。 |
| II. Major Tasks | | 二、主要任务 |
| 6. Promotion of standards for review and approval of drugs: Drugs shall be divided into new drugs and generic drugs. New drugs shall be redefined as “drugs that have not been on sales on the market in China and abroad” from the current definition of “drugs that have not been on sale on the market in China”. According to the originality and novelty of the material basis, new drugs shall be divided into innovative drugs and modified new drugs. Generic drugs shall be redefined as “drugs that are made after original ones and that are in conformity with the latter in terms of quality and curative effect” from the current definition of “drugs made after those that are already of national standards”. In accordance with the aforesaid principle, classification for registration of drugs shall be readjusted. In any evaluation, review and approval of generic drugs, the original drugs concerned shall be taken as reference preparations, to ensure that newly approved generic drugs shall be in conformity with the original drugs in terms of quality and curative effect. For applications for registration of drugs accepted for processing before the start of reforms, they shall be evaluated, reviewed and approved in accordance with the previous provisions on a continued basis, and problems concerning conformity with the original drugs concerned in terms of quality and curative effect shall be gradually solved in the work of assessment of conformity of quality. Where enterprises file an application of their own accord for review and approval in accordance with new standards that are in conformity with the original drugs concerned in terms of quality and curative effect, a green passage can be established, and the fee therefor shall be charged by the fee charge standards for application for registration of new drugs, to accelerate evaluation, review and approval thereof. The aforesaid reforms shall be carried out in pilot projects of chemical drugs, after authorization in accordance with the statutory procedure. | | （六）提高药品审批标准。将药品分为新药和仿制药。将新药由现行的“未曾在中国境内上市销售的药品”调整为“未在中国境内外上市销售的药品”。根据物质基础的原创性和新颖性，将新药分为创新药和改良型新药。将仿制药由现行的“仿已有国家标准的药品”调整为“仿与原研药品质量和疗效一致的药品”。根据上述原则，调整药品注册分类。仿制药审评审批要以原研药品作为参比制剂，确保新批准的仿制药质量和疗效与原研药品一致。对改革前受理的药品注册申请，继续按照原规定进行审评审批，在质量一致性评价工作中逐步解决与原研药品质量和疗效一致性问题；如企业自愿申请按与原研药品质量和疗效一致的新标准审批，可以设立绿色通道，按新的药品注册申请收费标准收费，加快审评审批。上述改革在依照法定程序取得授权后，在化学药品中进行试点。 |
7. Promotion of evaluation of conformity of the quality of generic drugs: For generic drugs that have been approved for marketing, they shall undergo evaluation of quality conformity in different phases and in different batches, in accordance with the principle of conformity with the original drugs concerned in terms of quality and curative effect. Drug producers shall conduct quality conformity evaluation of its products against reference preparations in accordance with the methodology prescribed, and shall submit the results of evaluation to China Food and Drug Administration. Reference preparations shall be determined by China Food and Drug Administration after consulting experts for their opinions, and can be either original drugs or the same types of drugs that are internationally recognized. Where there is no reference preparation, the drug producers concerned shall conduct clinical efficacy test. For generic drugs that have not passed evaluation of quality conformity within the prescribed time limit, they shall not be eligible for re-registration. For generic drugs that have passed evaluation of quality conformity, they shall be permitted to have annotations thereof on the instructions for use and labels, and support shall be extended to them in terms of clinical use, purchasing through public bidding, medical care reimbursement, etc. In the work of evaluation of quality conformity, where it is necessary to change technology already approved, supplementary application shall be filed in accordance with the relevant provisions of the Measures for Management Over Drug Registration, and China Food and Drug Administration shall establish a green passage therefor, to accelerate the process of evaluation, review and approval. The work of evaluation of quality conformity shall first of all be carried out on generic drugs whose market supply was approved before entry into force of the Measures for Management Over Drug Registration revised in 2007. The names of enterprises drafting standards for drugs shall be annotated in the National Pharmacopoeia, and enterprises shall be encouraged to improve the standards and quality of drugs supplied to the market by means of technological progress. The quality of patent drugs of traditional Chinese medicine shall be improved, and the work of re-evaluation of the safety of injections of traditional Chinese medicine shall be actively promoted.
．．．．．． | | （七）推进仿制药质量一致性评价。对已经批准上市的仿制药，按与原研药品质量和疗效一致的原则，分期分批进行质量一致性评价。药品生产企业应将其产品按照规定的方法与参比制剂进行质量一致性评价，并向食品药品监管总局报送评价结果。参比制剂由食品药品监管总局征询专家意见后确定，可以选择原研药品，也可以选择国际公认的同种药品。无参比制剂的，由药品生产企业进行临床有效性试验。在规定期限内未通过质量一致性评价的仿制药，不予再注册；通过质量一致性评价的，允许其在说明书和标签上予以标注，并在临床应用、招标采购、医保报销等方面给予支持。在质量一致性评价工作中，需改变已批准工艺的，应按《药品注册管理办法》的相关规定提出补充申请，食品药品监管总局设立绿色通道，加快审评审批。质量一致性评价工作首先在2007年修订的《药品注册管理办法》施行前批准上市的仿制药中进行。在国家药典中标注药品标准起草企业的名称，激励企业通过技术进步提高上市药品的标准和质量。提高中成药质量水平，积极推进中药注射剂安全性再评价工作。
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