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
Deepening the Reform of Evaluation and Approval System to Encourage Innovation in Drugs
and Medical Devices
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。
China has en its drug and medical devices industry develop rapidly in recent years , with innovation and entrepreneurship on the increa. Reform of the drug and medical device evaluation and approval system has followed. China’s drug and medical devices industry tends to lack technological innovation and support, however, while the quality of marketed products falls far behind international standards. To promote the structural reform of and technical innovations in the drugs and medical devices industry, enhancing the industry’s competitiveness and meet the clinical needs of the general public, China has adopted far reaching reforms of evaluation and approval system to encourage innovation in drugs and medical devices .
一、改革临床试验管理
Reform clinical trial management
（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。
Accrediting clinical trial institutions through registration.
After registering and submitting the necessary documents via the website designated by the China Food and Drug Administration (CFDA), an institution that fulfills the conditions for conducting clinical trials may start to conduct trials on behalf of drugs and medical devices registration applicants. The principal rearcher of a clinical trial is required to hold a nior title and should have already participated in at least three clinical trials. The registration applicant may engage a third party to evaluate and certify whether a clinical trial institution posss the required conditions. The u of non-governmental resources to invest in and establish clinical trial institutions is encouraged. Further
regulations on the administration of clinical trial organizations will be formulated by theCFDA together with the National Health and Family Planning Commission (NHFPC).
（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。
Supporting clinical trial institutions and rearchers in carrying out clinical trials.
Medical institutions, medical rearch organizations, and medical colleges and universities will be supported in participating in clinical trials. Clinical trials conditions and capabilities will be incorporated as criteria for accrediting medical institutions. A parate asssment and examination system will be established for evaluating medical institutions conducting clinical trials. Hospital beds ud only for clinical trials will not be counted in the total number of hospital beds in such medical ins
titutions, and the efficiency, turnover rate and utilization rate of hospital beds will not be ud as asssment indicators. The tup of full-time clinical trial departments by medical institutions will be encouraged. Such departments will be staffed by professional clinical trial rearchers. Organizations should increa performance-bad pay distribution and incentive mechanisms as well as ensure the proper income level of clinical trial rearchers. Participation of clinicians in technical innovation activities for drugs and medical devices is encouraged. In terms of position and title-bad promotions, among other issues, clinical trial rearchers should be treated in the same manner as clinicians. Foreign enterpris and scientific rearch institutions are permitted to conduct clinical trials of new drugs simultaneously in China in accordance with the laws and regulations.
（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。
Perfecting the ethics committee mechanism.
Clinical trials must conform to ethical and moral standards, They must guarantee that participants are informed with sufficient trial information prior to their voluntary participation, that they have understood and signed the Informed Connt Form, and that the participants’ safety, health, rights and interests are fully protected. The clinical trial institutions should establish an ethics committee responsible for reviewing the clinical trial protocols undertaken by the clinical trial institution, reviewing and supervising qualifications of clinical trial rearchers, supervising clinical trials and receiving inspection from regulatory departments. Each region may establish a regional ethics committee as needed to provide guidance for the ethics review of clinical trial institutions, to accept commissions, to conduct ethics review of clinical trial protocols from institutions or registration applicants that do not fulfill the conditions of an ethics review, and to supervi the conduct of clinical trials. The NHFPC, the traditional Chine medicine administration departments and CFDA will strengthen the administration, guidance, and business supervision of the work of the ethics committees.
（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。
Increasing the efficiency of ethics reviews.
Prior to submission of a clinical trial application, the applicant should first submit the clinical trial protocol to the ethics committee of the clinical trial institution for review and approval. In the event that a multi-center clinical trial is to be conducted in China, after an ethics review by the leading clinical trial institution, other member entities must accept the review conclusions reached by the leading institution to avoid repetitive reviews. The State Clinical Rearch Center for Medical Science and clinical trial institutions that undertake national key science and technology programs and national key R&D programs will integrate their resources to establish a uniform ethics review platform and gradually advance the mutual recognition of ethics committee reviews.
形容秋天的四字词语（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。红豆汤圆的做法
Optimizing the review procedures for clinical trials.
A mechanism for communication and exchange between applicants and the evaluation authorities will be established and perfected. Prior to the receipt of the applications for clinical trials of drugs and clinical trials of medical devices that require approval, the evaluation authorities must communicate with the applicants via conference where opinions and suggestions will be propod. In the event that the CFDA does not issue any review opinion, either rejecting or questioning the application, within a certain period of time after the receipt of the application, the clinical trial will be deemed approved, and the applicant may conduct the clinical trials according to the submitted protocols. During the cour of a clinical trial, if there is a change in the clinical trial protocol, and a significant pharmaceutical change or a non-clinical study safety issue aris, the registration applicant will promptly report the change to the evaluation authorities. In the event that safety-related issues or other risks are discovered, the registration applicant mustpromptly revi the clinical trial protocols, a
nd suspend or terminate the clinical trial. The drug registration applicants may issue on their own, or commission inspection institutions to issue, testing reports on the clinical trial samples, shouldsubmit the reports together with samples to the drug evaluation authority, and should make sure that the actual sample ud in the clinical trial is consistent with the submitted samples. The approval process for human genetic resources activities involving international cooperation in clinical trials will be optimized to speed up the clinical trial process.
（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。
Accepting overas clinical trial data.
美妆图片
Clinical trial data obtained overas from multi-centers may be ud in the registration application in China if the data conforms to the relevant requirements for the registration of drugs and medical devices in China. With respect to a first-time application for a marketing authorization of a drug or medical device in China, the registration applicant must provide clinical trial data to show whether any racial difference exists.
（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。
关于雨水的古诗
Supporting extended clinical trials.
With respect to drugs and medical devices currently under a clinical trial and ud for treating rious life-threatening dias that have no current or effective treatment, if preliminary obrvation indicates that such drugs and medical devices may be beneficial and conform to ethical requirements, such drugs and medical devices may, with informed connt, be ud on other patients within the institution conducting the clinical trial, and their safety data may be ud in the registration application.
（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。
Investigating and penalizing falsification of clinical trial data strictly.台湾三杯鸡
Both the signatories to a clinical trial commission agreement and rearchers of a clinical trial are the primary responsible persons for the clinical trial data, and will assume all legal responsibilities for the reliability of the clinical trial data. A review model bad on risks and evaluation needs will be established. On-site inspections and for-cau inspections on non-clinical rearch and clinical trials will be strengthened and the results of the inspection will be open to the public. If the rearch institution fails the inspection, the data it generates will not be accepted; if there are authenticity issues, the evaluation authority will promptly initiate an investigation and the responsible persons of any relevant non-clinical rearch or clinical trials institutions, the responsible persons who provide fal reports, the registration applicants and the responsible persons of contracting rearch organizations will all be held liable in accordance with the law; tho who refu, evade or impede inspections will receive strict penalties in accordance with the law. Applicants who voluntarily identify and promptly report the issues may have their penalties reduced accordingly.五一法定
二、加快上市审评审批
Accelerate the evaluation and approval for marketing authorizations
（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。
梦见老家Accelerating the evaluation and approval of clinical drugs and medical devices with an urgent need. With respect to drugs and medical devices ud for treating rious life-threatening dias that have no current or effective treatment, and drugs and medical devices that are of other urgent needs in public health, if clinical trial indicators at the early and middle phas show curative effects and their clinical value can be anticipated, such drugs and medical devices may be conditionally approved for marketing authorization. Enterpris applying for such conditional approval must formulate a risk control plan and conduct clinical trials according to the requirements. Rearch and development of new drugs and innovative medical devices will be encouraged. New drugs and innovative medical devices supported by national key science and technology programs and national key rearch and development programs, and new drugs and innovative medical devices under clinical trials by the State Clinical Rearch Center for Medical Science and approved by the managing department of the Center will be given priority status for evaluation and approval.
爬上屋顶
（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。
Supporting the rearch and development of drugs and medical devices for treating orphan dias. NHFPC or the relevant industry association it commissions will publish a catalog of orphan dias and establish a mechanism for registration of patients suffering from the orphan dias. Registrants for drugs and medical devices for treating orphan dias may apply to simplify or waive clinical trials. Drugs and medical devices for treating orphan dias that have been approved for marketing authorization overas may be approved conditionally for marketing authorization. Enterpris applying for such conditional approval must formulate a risk control plan and conduct clinical trials according to the requirements.
（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。
Strictly controlling the evaluation and approval of injectable drugs.
Conversion from oral preparations to injectable drugs will be strictly controlled, and if the oral preparations meet the relevant clinical needs, the injectable drugs will not be given marketing authorization approval; conversion from intramuscular injectable drugs to intravenous injectable drugs will be strictly controlled, and if the intramuscular injectable drugs meet the relevant clinical needs, relevant intravenous injectable drugs will not be given marketing authorization approval. Applications for conversion among large-volume injectable drugs, small-volume injectable drugs,
