| The General Office of the CPC Central Committee and the General Office of the State Council on Issuing the Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices | | 中共中央办公厅、国务院办公厅印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》 |
| (October 2017) | | （2017年10月） |
| Currently, China's drug and medical device industries see quick development, thriving innovation and entrepreneurship, and constant advancement of the reform of the evaluation and approval systems. Nevertheless, generally, China's drugs and medical devices are insufficiently supported by science and technology innovation, and there exists a gap between the quality of products sold on markets and international advanced standards. For purposes of promoting structural adjustment and technology innovation in drug and medical device industries, improving industrial competitiveness, and meeting the clinical need of the general public, the following opinions on deepening the reform of the evaluation and approval systems and encouraging innovation on drugs and medical devices are hereby offered. | | 当前，我国药品医疗器械产业快速发展，创新创业方兴未艾，审评审批制度改革持续推进。但总体上看，我国药品医疗器械科技创新支撑不够，上市产品质量与国际先进水平存在差距。为促进药品医疗器械产业结构调整和技术创新，提高产业竞争力，满足公众临床需要，现就深化审评审批制度改革鼓励药品医疗器械创新提出以下意见。 |
| I. Reforming the administration of clinical trials | | 一、改革临床试验管理 |
| (1) Implementing the recordation administration of clinical trial body qualification accreditation. A body qualified for clinical trials may, upon making registration and recordation on the website designated by the food and drug regulation department, conduct clinical trials as entrusted by registration applicants of drugs or medical devices. The main investigator in a clinical trial shall have a senior professional title and have participated in three or more clinical trials. A registration applicant may hire a third party to assess and certify whether the clinical trial body is qualified. Social resources shall be encouraged to invest in or fund clinical trial bodies. The China Food and Drug Administration shall develop provisions on the administration of clinical trial bodies in conjunction with the National Health and Family Planning Commission. | | （一）临床试验机构资格认定实行备案管理。具备临床试验条件的机构在食品药品监管部门指定网站登记备案后，可接受药品医疗器械注册申请人委托开展临床试验。临床试验主要研究者应具有高级职称，参加过3个以上临床试验。注册申请人可聘请第三方对临床试验机构是否具备条件进行评估认证。鼓励社会力量投资设立临床试验机构。临床试验机构管理规定由食品药品监管总局会同国家卫生计生委制定。 |
| (2) Supporting clinical trial bodies and personnel in conducting clinical trials. Medical institutions, medical research institutions and medicine universities shall be supported in conducting clinical trials, and the conditions and capacity for clinical trials shall be included in the rating of medical institutions. For medical institutions conducting clinical trials, a separate assessment and appraisal system shall be established, beds used only for clinical trials shall not be included in the total beds of the medical institutions, and appraisal indicators such as profit, turnover and use of beds shall not be specified. Medical institutions shall be encouraged to establish separate clinical trial departments and assign professional clinical trial investigators. The entity performance-related pay distribution incentive mechanism shall be improved to ensure the income of clinical trial investigators. Clinical doctors shall be encouraged to participate in the innovation on drug and medical device technologies, and clinical trial investigators are treated the same as clinical doctors in the aspects such as job promotion and title ranking. Overseas enterprises and scientific research institutions shall be allowed to synchronically conduct clinical trials in new drug development in China. | | （二）支持临床试验机构和人员开展临床试验。支持医疗机构、医学研究机构、医药高等学校开展临床试验，将临床试验条件和能力评价纳入医疗机构等级评审。对开展临床试验的医疗机构建立单独评价考核体系，仅用于临床试验的病床不计入医疗机构总病床，不规定病床效益、周转率、使用率等考评指标。鼓励医疗机构设立专职临床试验部门，配备职业化的临床试验研究者。完善单位绩效工资分配激励机制，保障临床试验研究者收入水平。鼓励临床医生参与药品医疗器械技术创新活动，对临床试验研究者在职务提升、职称晋升等方面与临床医生一视同仁。允许境外企业和科研机构在我国依法同步开展新药临床试验。 |
| (3) Improving the ethics committee mechanism. Clinical trials shall conform to ethical and moral standards, and shall be ensured that human subjects are informed of adequate research information before their voluntary participation and understand and shall sign an informed consent document so as to protect their safety, health, rights and interests. A clinical trial body shall establish an ethics committee responsible for examining the body's clinical trial plans, reviewing and supervising the qualifications of clinical trial investigators, supervising the conduct of clinical trials, and accepting the inspection of regulatory departments. Each region may establish a regional ethics committee to guide clinical trial bodies' ethnics review, conduct ethnics reviews of clinical trial plans as entrusted by bodies without ethnics review conditions or registration applicants, and supervise clinical trials. Health and family planning, traditional Chinese medicine administration, and food and drug regulation, etc. shall strengthen the administrative guidance to and business supervision of ethics committees. | | （三）完善伦理委员会机制。临床试验应符合伦理道德标准，保证受试者在自愿参与前被告知足够的试验信息，理解并签署知情同意书，保护受试者的安全、健康和权益。临床试验机构应成立伦理委员会，负责审查本机构临床试验方案，审核和监督临床试验研究者的资质，监督临床试验开展情况并接受监管部门检查。各地可根据需要设立区域伦理委员会，指导临床试验机构伦理审查工作，可接受不具备伦理审查条件的机构或注册申请人委托对临床试验方案进行伦理审查，并监督临床试验开展情况。卫生计生、中医药管理、食品药品监管等部门要加强对伦理委员会工作的管理指导和业务监督。 |
| (4) Raising the efficiency of ethnic reviews. A registration applicant shall, before applying for a clinical trial, submit a clinical trial plan to the clinical trial body's ethics committee for review and approval. In the case of a clinical trial conducted in several centers in China, where the leading entity of the clinical trial has conducted the ethnics review, the other member entities shall accept the review conclusions of the leader entity, instead of repeating the review. The National Clinical Medicine Research Center and clinical trial bodies tasked with major national science and technology projects and key national research and development plans support projects shall integrate their resources to establish a unified ethnic review platform and gradually advance mutual recognition of ethnic reviews. | | （四）提高伦理审查效率。注册申请人提出临床试验申请前，应先将临床试验方案提交临床试验机构伦理委员会审查批准。在我国境内开展多中心临床试验的，经临床试验组长单位伦理审查后，其他成员单位应认可组长单位的审查结论，不再重复审查。国家临床医学研究中心及承担国家科技重大专项和国家重点研发计划支持项目的临床试验机构，应整合资源建立统一的伦理审查平台，逐步推进伦理审查互认。 |
| (5) Optimizing the approval procedures for clinical trials. A mechanism of communication and exchange between registration applicants and evaluation bodies shall be established and improved. Before accepting applications for drug clinical trials and medical device clinical trials requiring approval, the evaluation body shall meet and communicate with registration applicants and offer opinions and suggestions. The food and drug registration department shall be deemed to have given its consent if it does not give a denial or doubting opinions within a given period after accepting an application for clinical trial, and the registration applicant may conduct the clinical trial according to the submitted plan. During a clinical trial, in the case of modification of the clinical trial plan, or material medical modification, or a nonclinical investigation safety problem, the registration applicant shall promptly file the modification with the evaluation body; and in the case of safety or other risks, the clinical trial plan shall be revised in a timely manner, or the clinical trial shall be suspended or terminated. A drug registration applicant may issue an inspection report on samples in the clinical trial alone or by entrusting an inspection institution, submit it to the drug evaluation body, attaching the samples, and ensure the consistency between the samples actually used in clinical trials and submitted samples. The procedures for approving human genetic resource activities involving international cooperation in clinical trials shall be optimized to accelerate the progress of clinical trials. | | （五）优化临床试验审批程序。建立完善注册申请人与审评机构的沟通交流机制。受理药物临床试验和需审批的医疗器械临床试验申请前，审评机构应与注册申请人进行会议沟通，提出意见建议。受理临床试验申请后一定期限内，食品药品监管部门未给出否定或质疑意见即视为同意，注册申请人可按照提交的方案开展临床试验。临床试验期间，发生临床试验方案变更、重大药学变更或非临床研究安全性问题的，注册申请人应及时将变更情况报送审评机构；发现存在安全性及其他风险的，应及时修改临床试验方案、暂停或终止临床试验。药品注册申请人可自行或委托检验机构对临床试验样品出具检验报告，连同样品一并报送药品审评机构，并确保临床试验实际使用的样品与提交的样品一致。优化临床试验中涉及国际合作的人类遗传资源活动审批程序，加快临床试验进程。 |
| (6) Accepting overseas clinical trial data. Clinical trial data obtained in multiple overseas centers, conforming to China's requirements for registration of drugs and medical devices, may be used for the application for registration in China. In the case of drugs and medical devices the marketing of which is applied for in China for the first time, registration applicants shall provide clinical trial data on racial differences. | | （六）接受境外临床试验数据。在境外多中心取得的临床试验数据，符合中国药品医疗器械注册相关要求的，可用于在中国申报注册申请。对在中国首次申请上市的药品医疗器械，注册申请人应提供是否存在人种差异的临床试验数据。 |
| (7) Supporting expanded clinical trials. A drug or a medical device under a clinical trial, which is used to treat diseases seriously detrimental to life and for which there is no effective treatment means, which may bring benefits according to preliminary observations, and which conforms to ethical requirements, may be used to cure other patients within the clinical trial body with their informed consent, and the safety data may be used for registration application. | | （七）支持拓展性临床试验。对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段疾病的药品医疗器械，经初步观察可能获益，符合伦理要求的，经知情同意后可在开展临床试验的机构内用于其他患者，其安全性数据可用于注册申请。 |
| (8) Seriously investigating and dealing with data fraud. Signatories of entrusted clinical trial agreements and clinical trial investigators, as primary persons responsible for clinical trial data, shall assume legal liability for the reliability of clinical trial data. An inspection mode oriented on risks and evaluation need shall be developed, the on-site inspection and for-cause inspection of nonclinical investigations and clinical trials shall be strengthened, and inspection results shall be publicly disclosed. In the case of failure in inspection, relevant data shall not be accepted; in the case of authenticity problem, investigation shall be opened in a timely manner, and the persons in charge of the relevant nonclinical investigation body or the clinical trial body, persons liable for providing false reports, registration applicants, and persons in charge of investigation organization contractors shall be held accountable by law; and one that refuses, doges or obstructs inspection shall be heavily punished by law. A registration applicant who voluntarily discovers problems and makes a timely report may be subject to lighter punishment or exempt from punishment, as the case may be. | | （八）严肃查处数据造假行为。临床试验委托协议签署人和临床试验研究者是临床试验数据的第一责任人，须对临床试验数据可靠性承担法律责任。建立基于风险和审评需要的检查模式，加强对非临床研究、临床试验的现场检查和有因检查，检查结果向社会公开。未通过检查的，相关数据不被接受；存在真实性问题的，应及时立案调查，依法追究相关非临床研究机构和临床试验机构责任人、虚假报告提供责任人、注册申请人及合同研究组织责任人的责任；拒绝、逃避、阻碍检查的，依法从重处罚。注册申请人主动发现问题并及时报告的，可酌情减免处罚。 |
| II. Accelerating marketing evaluation and approval | | 二、加快上市审评审批 |
| (9) Accelerating the evaluation and approval of drugs and medical devices much needed clinically. A drug or a medical device under a clinical trial, which is used to treat diseases seriously detrimental to life and for which there is no effective treatment means, and which is urgently needed in public health or other aspects, may be approved to be marketed conditionally, where the early-phase and intermediate indicators of the clinical trial indicate its therapeutic effect, and where its clinical value may be predicted, and the enterprise shall make a risk management and control plan and conduct research as required. The research and development of new drugs and innovative medical devices shall be encouraged, and new drugs and innovative medical devices supported by major national science or technology projects and key national research and development plans or for which the National Clinical Medicine Research Center conducts clinical trials and which the Center's administrative department accredits shall be evaluated and approved in priority. | | （九）加快临床急需药品医疗器械审评审批。对治疗严重危及生命且尚无有效治疗手段疾病以及公共卫生方面等急需的药品医疗器械，临床试验早期、中期指标显示疗效并可预测其临床价值的，可附带条件批准上市，企业应制定风险管控计划，按要求开展研究。鼓励新药和创新医疗器械研发，对国家科技重大专项和国家重点研发计划支持以及由国家临床医学研究中心开展临床试验并经中心管理部门认可的新药和创新医疗器械，给予优先审评审批。 |
| (10) Supporting the research and development of drugs and medical devices for treatment of rare diseases. The National Health and Family Planning Commission or the relevant industry association (society) it entrusted shall publish a rare diseases catalog and establish a rare-disease patient registration system. An applicant for the registration of a drug or medical device for treatment of a rare disease may apply for a reduced clinical trial or exemption from clinical trial. A drug or medical device for treatment of rare disease whose marketing has been approved overseas may be approved to be marketed conditionally, and the enterprise shall make a risk management and control plan and conduct research as required. | | （十）支持罕见病治疗药品医疗器械研发。国家卫生计生委或由其委托有关行业协（学）会公布罕见病目录，建立罕见病患者登记制度。罕见病治疗药品医疗器械注册申请人可提出减免临床试验的申请。对境外已批准上市的罕见病治疗药品医疗器械，可附带条件批准上市，企业应制定风险管控计划，按要求开展研究。 |
(11) Making strict evaluation and approval of injectable drugs. The change of oral drugs to injectable ones shall be strictly controlled, and if an oral drug is sufficient to meet clinical demand, the marketing its injectable substitute may not be approved. The change of injectable drugs administered by intramuscular injection to injectable ones administered by intravenous injection shall be strictly controlled, and if an injectable drug administered by intramuscular injection is sufficient to meet clinical demand, the marketing its injectable substitute administered by intravenous injection may not be approved. An application for change of drug administration among large volume injection, small volume injection, and powder for solution for injection shall not be approved unless the clinical advantage is conspicuous.
．．．．．． | | （十一）严格药品注射剂审评审批。严格控制口服制剂改注射制剂，口服制剂能够满足临床需求的，不批准注射制剂上市。严格控制肌肉注射制剂改静脉注射制剂，肌肉注射制剂能够满足临床需求的，不批准静脉注射制剂上市。大容量注射剂、小容量注射剂、注射用无菌粉针之间互改剂型的申请，无明显临床优势的不予批准。
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