中共中央办公厅、国务院办公厅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

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’s pharmaceutical and medical device industry is developing rapidly, innovation and start-up are in their ascendant and reform of the review and approval system has been continuously carried forward. However, in general, China still lacks a full range of support for pharmaceutical and medical device innovation, and there is still a gap between the marketed product quality level and the international advanced level. To promote the pharmaceutical and medical device industry adjustment and technological innovation, to enhance industrial competitiveness and to meet public clinical needs, we hereby put forward the following opinions on deepening the reform of the examination and approval system to encourage the innovation of drugs and medical devices as follows.

一、改革临床试验管理

I. The Reform of 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。

1.   Establish a record-filing system for the qualification of clinical trial institutions. An institution that has met conditions for clinical trials can carry out clinical trials as entrusted by a drug or medical device registration applicant as long as it has filed a record on a website designated by the food and drug regulatory authorities. Clinical trials’ principal researchers shall have senior professional titles and have participated in more than 3 clinical trials. The registration applicant may appoint a third party to evaluate the certification of the clinical trial institution. Private investors are encouraged to set up clinical trial institutions. The regulations for the administration of clinical trial institutions shall be formulated by the China Food and Drug Administration and the National Health and Family Planning Commission.

（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。

2.   Support clinical trial institutions and personnel to carry out clinical trials. Support medical institutions, medical research institutions, medical colleges and universities to carry out clinical trials, with clinical trial conditions and competency incorporated into the medical institutions class assessment. A separate examination system shall be established for the clinical trial of the medical institutions, in which beds used only for clinical trials will not be included in the total number of the medical institution’s beds and no elements such as efficiency, turnover rate, utilization rate and other evaluation indicators of the beds will be required. Medical institutions are encouraged to set up full-time clinical trial departments equipped with professional clinical trial researchers. The unit performance wage distribution incentive mechanism shall be improved to ensure clinical trial researchers income at an appropriate level. Clinicians are encouraged to participate in drugs and medical devices technology innovation activities, and the clinical trial researchers shall be treated equally with clinicians in the job promotion, title promotion and other aspects. Foreign enterprises and scientific research institutes are allowed to conduct clinical trials simultaneously in China for new drugs subject to relevant rules and laws.

（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。

3.   Consummate the ethics committee mechanism. Clinical trials shall be consistent with ethical standards, ensuring that before voluntarily participation, subjects are sufficiently informed with test information, understand and sign informed consent letters so as to protect their safety, health and other rights. The clinical trial institution shall set up an ethics committee to review the clinical trial program of the institution, to verify and supervise the qualifications of clinical trial researchers and to supervise clinical trials, and shall be examined by the regulatory authorities. Local ethics committees can be set up to guide clinical trial institutions ethical reviews, and to conduct ethical reviews of clinical trial programs according to the unqualified institutions or registration applicants’ assignment and to supervise clinical trials. Regulatory authorities on health and family planning, traditional Chinese medicine management, food and drug and other departments shall strengthen the work on the guidance and business supervision of 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。

4.   Streamline the efficiency of ethical reviews. Registration applicants shall submit the clinical trial program to the clinical trial institution ethics committee for review and approval before processing the clinical trial. Once the multi-center clinical trial within Chinese territory is ethically reviewed and approved by the clinical trial team head’s institution, other member units shall recognize the team head’s institution’s review conclusions and the multi-center clinical trial shall not be repeatedly reviewed. National Clinical Medical Research Center and other clinical trial institutions undertaking national major projects for science and technology and national key R&D facilitating programs, shall integrate resources to establish a unified ethical review platform and gradually promote the mutual recognition for ethical reviews.

（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。

5. Optimize the clinical trial approval procedures. The communication mechanism between the applicant and the review institution shall be established and improved. Reviewing authority should communicate with applicants and give comments before accepting the applications of drug clinical trials and medical devices clinical trials. Once accepted, if the reviewing authority fails to deny or question the application within a given term, applicants will be permitted to conduct clinical trials. During the clinical trial, the applicant shall promptly submit any clinical trial program changes, major pharmacy changes or non-clinical research safety issues to the review institution; once any safety issues or other risks have been found, the clinical trial program shall correspondently be revised, suspended or terminated immediately. The applicant may submit a test report delivered by itself or by an assigned assessment institution, together with a sample, to the drug review institution and ensure that the actual sample used in the clinical trial is consistent with the submitted sample. The approval process for human genetic resources activities involving international cooperation in clinical trials shall be optimized and the clinical trial process shall be speeded up.

（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。

6.    Accept overseas clinical trial data. If the clinical trial data obtained from overseas multi-centers are in compliance with the relevant registration requirements for Chinese drugs and medical devices, it can be used to apply for a registration in China. For drugs and medical devices that was first publicly provided in China, the applicant shall provide clinical trial data specifying whether there are racial differences or not.

（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。

7.    Support extended clinical trials. Drugs and medical devices that are under clinical trials for the treatment of diseases which are life-threatening as well as have not been proved to be effective in a treatment can be applied to other institution patients during clinical trials as long as the initial investigation proves potential effectiveness, the ethical review has been processed and the patient understands and agrees to use, and the safety data collected under this circumstance can be used in registration applications.

（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。

8. Severely cracking down on practices of fabricating data. Parties who have entered into an agreement for clinical trials and the researcher of clinical trials shall be the first person bearing the responsibilities for data on clinical trials, and shall be held fully liable for the reliability of data on clinical trials. A review model based on risk and review requirements shall be established, strengthening on-site and reasonable inspections for clinical and non-clinical studies, and review results shall be accessible to the public. Related data shall not be accepted if such data fails in data reviews; any inspection department finds that the authenticity of application materials are in doubt, it shall place the case on file for investigation promptly. With regard to responsible persons of non-clinical research organizations and research organizations of clinical trials, and responsible person who provided fraud reports, and registered applicant as well as responsible persons of relevant contract research organizations, their legal liabilities shall be investigated in accordance with the law; anyone who refuses to accept, evades or impedes an inspection shall be given a heavier punishment. However, if the applicant finds that the data on clinical trials is in doubt and voluntarily reports to the regulator, the regulator can exempt it from punishment or impose a lighter punishment.

二、加快上市审评审批

II.    Speed up the Marketing Review and Approval

（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。

9.   Speed up the review and approval for urgently needed drugs and medical devices. For the drugs and medical devices urgently needed for treatment of serious life-threatening diseases without proven effectiveness or other public health issues, as long as clinical trials in early and mid-term stages’ indicators show their efficacy with predictable clinical value, such drugs and medical devices can be approved to be marketed with conditions, in this case enterprises shall formulate a risk control plan to carry out researches as required. New drugs and innovation on medical devices researches and development are encouraged; new drugs and innovative medical devices pertains to the national science and technology major projects, supported by national key R&D programs, and whose clinical trial is carried out by the national clinical trial medical research center and approved by the central management shall be reviewed and approved with priority.

（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。

10.  Support drugs and medical devices R&D on rare diseases. National Health and Family Planning Commission or other entrusted relevant industry associations (study centers) will publish the rare diseases catalogue and establish the rare disease registration system. Rare diseases drugs and medical devices registration applicants may apply for a clinical trial exemption. Rare diseases drugs and medical devices that have been approved for marketing abroad may be approved for conditioned marketing. The enterprise shall formulate a risk control plan and carry out researches as required.

（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。

11.  High-standard requirements for drug injection reviews and approvals. Strictly control shall be imposed to an oral preparation converting into an injection preparation. An oral preparation which meets the clinical standards shall not be approved as an injection preparation product. Strictly control shall be imposed to an intramuscular injection converting into an intravenous injection preparation. An intramuscular injection which meets clinical standards shall not be approved as an intravenous preparation product. Application to convert the variety of formulations among large volume injection, small volume injection and injection of sterile powder shall not be approved as long as no obvious clinical advantage has been found to be yielded from such approval.

（十二）实行药品与药用原辅料和包装材料关联审批。原料药、药用辅料和包装材料在审批药品注册申请时一并审评审批，不再发放原料药批准文号，经关联审评审批的原料药、药用辅料和包装材料及其质量标准在指定平台公示，供相关企业选择。药品上市许可持有人对生产制剂所选用的原料药、药用辅料和包装材料的质量负责。

12.  Implement associated approvals of drugs and pharmaceutical raw materials and packaging materials. APIs, pharmaceutical excipients and packaging materials shall be reviewed and approved simultaneously and there will not be any new API approval numbers; APIs, pharmaceutical excipients and packaging materials and its quality standards shall be publicized in the designated platform for relevant enterprises’ selection. The marketed drug licensee shall be responsible for the quality of the APIs, pharmaceutical excipients and packaging materials used in the production.

（十三）支持中药传承和创新。建立完善符合中药特点的注册管理制度和技术评价体系，处理好保持中药传统优势与现代药品研发要求的关系。中药创新药，应突出疗效新的特点；中药改良型新药，应体现临床应用优势；经典名方类中药，按照简化标准审评审批；天然药物，按照现代医学标准审评审批。提高中药临床研究能力，中药注册申请需提交上市价值和资源评估材料，突出以临床价值为导向，促进资源可持续利用。鼓励运用现代科学技术研究开发传统中成药，鼓励发挥中药传统剂型优势研制中药新药，加强中药质量控制。

13.  Support the heritage and innovation of traditional Chinese medicines. Establish and improve the registration management system and technical evaluation system so as to ensure the consistence with the characteristics of traditional Chinese medicine, and adjust the relationship between the traditional advantages of traditional Chinese medicine and the requirements of modern drug research and development. New Chinese medicine shall emphasize its new effect; improved traditional Chinese medicines shall reflect the advantages of their clinical application; classical Chinese medicine shall be reviewed and approved with the simplified standard; natural medicine shall be reviewed and approved with modern medical standards. Traditional Chinese medicine’s clinical research capacity shall be improved. Marketing value and resource assessment documents shall be submitted when a Chinese medicine is going through registering procedure, emphasizing a clinical value-oriented atmosphere, and promoting the sustainable use of resources. The use of modern science and technology research and development of traditional Chinese medicine and traditional Chinese medicine is encouraged to maximize traditional Chinese medicine’s advantages so as to develop new drugs and to strengthen the quality control.

（十四）建立专利强制许可药品优先审评审批制度。在公共健康受到重大威胁情况下，对取得实施强制许可的药品注册申请，予以优先审评审批。公共健康受到重大威胁的情形和启动强制许可的程序，由国家卫生计生委会同有关部门规定。

14. Set up a prioritized review and approval regime based on the compulsory licensing. Drug registration applications with compulsory licensing shall obtain prior reviews and approvals in which the public health is under threatening. Whether the public health is under threatening situation and compulsory licensing procedure triggering shall be prescribed by the national health commission and the relevant authorities.

三、促进药品创新和仿制药发展

III．Promote the Drug Innovation and Generic Drug Development

（十五）建立上市药品目录集。新批准上市或通过仿制药质量和疗效一致性评价的药品，载入中国上市药品目录集，注明创新药、改良型新药及与原研药品质量和疗效一致的仿制药等属性，以及有效成份、剂型、规格、上市许可持有人、取得的专利权、试验数据保护期等信息。

15.  Establish a marketed drug catalogue. New drugs that have been approved to be marketed or have passed the generic drugs quality and efficacy consistency evaluations shall be marketed in the China marketed drug catalogue, in which the following information shall be specified, the attributes of innovative drugs, improved new drugs and generic drugs is consistent with the quality and efficacy of the original drugs, together with the active ingredients, dosage forms, specifications,  marketing authorization holders, patent rights obtained, test data protection period and other information.

（十六）探索建立药品专利链接制度。为保护专利权人合法权益，降低仿制药专利侵权风险，鼓励仿制药发展，探索建立药品审评审批与药品专利链接制度。药品注册申请人提交注册申请时，应说明涉及的相关专利及其权属状态，并在规定期限内告知相关药品专利权人。专利权存在纠纷的，当事人可以向法院起诉，期间不停止药品技术审评。对通过技术审评的药品，食品药品监管部门根据法院生效判决、裁定或调解书作出是否批准上市的决定；超过一定期限未取得生效判决、裁定或调解书的，食品药品监管部门可批准上市。

16.  Explore ways to establish the drug patent linkage system. In order to protect the legitimate rights and interests of patentees, to reduce the risk of generic patent infringements, and to encourage the development of generic drugs, the link system between drug review and approval and the drug patent shall be explored and established. Drug registration applicants shall explain the relevant patents and ownership status when submitting the registration application, and inform the relevant drug patentee within the prescribed period. Where there is a dispute related to the patent right, the parties may sue to the court without interrupting drug technical reviews. The food and drug regulatory authorities may approve the marketing in accordance with the effective judgment, reward or mediation letter; in case that there is no effective judgment, reward or mediation letter after a certain period of time, food and drug regulatory authorities can approve the marketing.

（十七）开展药品专利期限补偿制度试点。选择部分新药开展试点，对因临床试验和审评审批延误上市的时间，给予适当专利期限补偿。

17.  Set up drug patent period compensation pilots system. Select certain new drugs to be in the pilot program, and give the appropriate patent period compensation due to the marketing delay caused by the postponement of clinical trials and review and approval.

（十八）完善和落实药品试验数据保护制度。药品注册申请人在提交注册申请时，可同时提交试验数据保护申请。对创新药、罕见病治疗药品、儿童专用药、创新治疗用生物制品以及挑战专利成功药品注册申请人提交的自行取得且未披露的试验数据和其他数据，给予一定的数据保护期。数据保护期自药品批准上市之日起计算。数据保护期内，不批准其他申请人同品种上市申请，申请人自行取得的数据或获得上市许可的申请人同意的除外。

18.  Improve and implement the drug test data protection system. Applicants who submit a registration application may submit a test data protection application simultaneously. For innovative drugs, rare disease treatment drugs, child special medicines, biological products of innovative treatment and personal owned and undisclosed test data as well as other data submitted by challenges to successfully registered drugs applicants, a certain data protection period shall be given. The data protection period shall commence from the date on which the drug is approved to be marketed. Other applicants are not allowed to apply for the same kind of drugs within the data protection period, except for the data acquired by the new applicant itself or the applicant has obtained consents from marketing authorization holder.

（十九）促进药品仿制生产。坚持鼓励创新与促进药品仿制生产、降低用药负担并重，定期发布专利权到期、终止、无效且尚无仿制申请的药品清单，引导仿制药研发生产，提高公众用药可及性。完善相关研究和评价技术指导原则，支持生物类似药、具有临床价值的药械组合产品的仿制。加快推进仿制药质量和疗效一致性评价。

19.  Promote the production of generic drugs. Persist in encouraging innovation as well as promoting the generic drugs production and reducing the burden of medication, issuing the drug list of which patent rights are expired, terminated, invalid and without generic application, guiding the development and production of generic drugs and improving the accessibility of public medication appropriately. Improve technical guidelines for relevant researches and evaluations to support the imitation for similar biological drugs, and drugs and medical devices combination products with the clinical value. Accelerate the evaluation of the quality and efficacy of generic drugs.

（二十）发挥企业的创新主体作用。鼓励药品医疗器械企业增加研发投入，加强新产品研发和已上市产品的继续研究，持续完善生产工艺。允许科研机构和科研人员在承担相关法律责任的前提下申报临床试验。使用国家财政拨款开展新药和创新医疗器械研发及相关技术研究并作为职务科技成果转化的，单位可以规定或与科研人员约定奖励和报酬的方式、数额和时限，调动科研人员参与的积极性，促进科技成果转移转化。

20.  Fulfill the main role of enterprises innovation. Encourage drugs and medical devices enterprises to increase R&D investment, to strengthen new products R&D and marketed products continuing study, and continuously improve the production process. Allow scientific research institutions and researchers to apply for clinical trials under circumstance that the institution and the researcher taking all relevant legal responsibilities. In the case of using national financial allocations to carry out new drugs and innovative medical devices R&D as well as related technical researches, employers are entitled to regulate or to make agreements with researchers over their rewards and reward methods, amounts and time limit so as to ensure researchers’ enthusiasm and to promote the science and technology results transformation.

（二十一）支持新药临床应用。完善医疗保险药品目录动态调整机制，探索建立医疗保险药品支付标准谈判机制，及时按规定将新药纳入基本医疗保险支付范围，支持新药研发。各地可根据疾病防治需要，及时将新药纳入公立医院药品集中采购范围。鼓励医疗机构优先采购和使用疗效明确、价格合理的新药。

21.  Support the clinical application of new drugs. Improve the dynamic adjustment mechanism for social insurance drug catalogue, explore the establishment of medical insurance drug payment standard negotiation system, support new drugs R&D in accordance with the provisions of new drugs into the basic medical insurance coverage. All localities can promptly include new drugs into centralized procurement scope based on the needs of disease prevention and control. Encourage medical institutions to give priority to purchase and use new drugs with clear efficacy and reasonable price.

四、加强药品医疗器械

全生命周期管理

IV.  Strengthen the Life-Cycle Management of Drugs and Medical Devices

（二十二）推动上市许可持有人制度全面实施。及时总结药品上市许可持有人制度试点经验，推动修订药品管理法，力争早日在全国推开。允许医疗器械研发机构和科研人员申请医疗器械上市许可。

22.  Promote the full-scale implementation of the marketing authorization holder (MAH) system. Timely summarize the pilot drug marketing authorization holder system experiences, promote the revision of drug management law, and strive to early launches around the country. Allow medical devices R&D institutions and researchers to apply for medical devices marketing authorizations.

（二十三）落实上市许可持有人法律责任。药品上市许可持有人须对药品临床前研究、临床试验、生产制造、销售配送、不良反应报告等承担全部法律责任，确保提交的研究资料和临床试验数据真实、完整、可追溯，确保生产工艺与批准工艺一致且生产过程持续合规，确保销售的各批次药品与申报样品质量一致，确保对上市药品进行持续研究，及时报告发生的不良反应，评估风险情况，并提出改进措施。

23.  Specify marketing authorization holders’ legal responsibilities. Drug marketing authorization holders are required to take full responsibility for pre-clinical research, clinical trials, manufacturing, sales distribution, adverse reaction reports, etc., so as to ensure that the submitted research data and clinical trial data are authentic, complete and traceable, to ensure the production process is in consistent with the approved process and continuous compliance with the production process, to ensure that the sales of the batches of drugs and consistent with the quality of the sample, and to ensure that the ongoing study of marketed drugs, timely reports any adverse reactions, assessment of risk, and propose improve measures shall be performed.

医疗器械上市许可持有人须对医疗器械设计开发、临床试验、生产制造、销售配送、不良事件报告等承担全部法律责任，确保提交的研究资料和临床试验数据真实、完整、可追溯，确保对上市医疗器械进行持续研究，及时报告发生的不良事件，评估风险情况，并提出改进措施。

Medical device marketing authorization holders shall take all legal liabilities for medical device design and development, clinical trials, manufactures, sales and distributions, adverse event reports, etc., and shall ensure that the submitted research data and clinical trial data are authentic, complete and traceable. Ensure marketed medical devices for continuous researches, adverse events promptly reports, risk assessments, and improvement measures proposals.

受药品医疗器械上市许可持有人委托进行研发、临床试验、生产制造、销售配送的企业、机构和个人，须承担法律法规规定的责任和协议约定的责任。

Any enterprises, institutions and individuals entrusted by medical device marketing authorization holders to conduct the R&Ds, clinical trials, manufactures, sales distributions shall be liable for breaching of contract or other responsibilities as stipulated in the laws, regulations and agreements

（二十四）建立上市许可持有人直接报告不良反应和不良事件制度。上市许可持有人承担不良反应和不良事件报告的主体责任，隐瞒不报或逾期报告的，依法从严惩处。食品药品监管部门应对报告的不良反应和不良事件进行调查分析，视情责令上市许可持有人采取暂停销售、召回、完善质量控制等措施。

24.  Establish a system in which marketing authorization holders directly reporting adverse reactions and adverse events. Where the marketing authorization holders undertake the main responsibilities for the adverse reactions and the adverse events reports, any conceal or delay of such reports shall be punished severely pursued to relevant laws. Food and drug regulatory authorities shall investigate and analyze the adverse reactions and adverse events mentioned in the report, and correspondently take appropriate measures including suspend sales, recall, quality control improvement and other measures.

（二十五）开展药品注射剂再评价。根据药品科学进步情况，对已上市药品注射剂进行再评价，力争用5至10年左右时间基本完成。上市许可持有人须将批准上市时的研究情况、上市后持续研究情况等进行综合分析，开展产品成份、作用机理和临床疗效研究，评估其安全性、有效性和质量可控性。通过再评价的，享受仿制药质量和疗效一致性评价的相关鼓励政策。

25.  Carry out drugs injection re-evaluations. According to pharmaceutical scientific progress, strive to complete the re-evaluation of marketed injections within 5 to 10 years. The marketing authorization holders shall conduct a comprehensive analysis of the research at the time of marketing and the continuous research after the marketing, carrying out research on product composition, mechanism of action and clinical efficacy, so as to assess the drug’s safety, effectiveness and quality control. Drugs which pass the re-evaluation process shall have same the relevant incentive policy treatment for the consistency of quality of generic drugs and efficacy.

（二十六）完善医疗器械再评价制度。上市许可持有人须根据科学进步情况和不良事件评估结果，主动对已上市医疗器械开展再评价。再评价发现产品不能保证安全、有效的，上市许可持有人应及时申请注销上市许可；隐匿再评价结果、应提出注销申请而未提出的，撤销上市许可并依法查处。

26.  Improve the medical devices re-evaluation system. The marketing authorization holders shall, on the basis of real time scientific progress and the assessment result of the adverse events, proactively re-evaluate the marketed medical devices. In case that the re-evaluation found that the drug cannot guarantee the safety and effectiveness of the product, the marketing authorization holders shall apply for a cancellation of the marketing authorization promptly; any conceal of the re-evaluation results or any failure to put forward a cancellation application shall be followed by marketing authorization revocation and punishment by means of related laws.

（二十七）规范药品学术推广行为。药品上市许可持有人须将医药代表名单在食品药品监管部门指定的网站备案，向社会公开。医药代表负责药品学术推广，向医务人员介绍药品知识，听取临床使用的意见建议。医药代表的学术推广活动应公开进行，在医疗机构指定部门备案。禁止医药代表承担药品销售任务，禁止向医药代表或相关企业人员提供医生个人开具的药品处方数量。医药代表误导医生使用药品或隐匿药品不良反应的，应严肃查处；以医药代表名义进行药品经营活动的，按非法经营药品查处。

27.  Regulate the academic promotion of drugs.  Marketing authorization holders shall file the list of medical representatives with the food and drug regulatory authorities and make it known to the public.  Medical representatives are responsible for the promotion of pharmaceuticals, instruction of drugs knowledge to medical staffs, and to listen to the views of clinical practical experience advice. Medical representatives’ academic promotion activities shall be carried out in public and subject to designated department’s record-filing administration. The medical representatives are prohibited to assume the task of drug sales and the medical representatives or related business personnel are prohibited to be provided with the number of medical prescriptions issued by doctors. Medical representatives mislead doctors to use drugs or conceal drugs adverse reactions shall be severely punished; impersonate the name of a medical representative to carry out drug businesses shall be convicted of the crime of illegal drugs operation.

五、提升技术支撑能力

V.   Enhance the Technical Support Capacity

（二十八）完善技术审评制度。建立审评为主导、检查检验为支撑的技术审评体系，完善审评项目管理人制度、审评机构与注册申请人会议沟通制度、专家咨询委员会制度，加强内部管理，规范审评流程。组建以临床医学专业人员为主，药学、药理毒理学、统计学等专业人员组成的药品审评团队，负责新药审评。组建由临床医学、临床诊断、机械、电子、材料、生物医学工程等专业人员组成的医疗器械审评团队，负责创新医疗器械审评。除生产工艺等技术秘密外，审评结论及依据全部公开，接受社会监督。统一第二类医疗器械审评标准，逐步实现国家统一审评。

28.  Improve the technical review system. Establish a review-oriented technical review system with the inspection and testing support, improve the review of the project manager system, review agencies and registration applicants conference communication system, expert advisory committee system, strengthen internal management and standardize the review process. Form a drug review team composed of clinical medicine professionals, pharmacy, pharmacology and toxicology, statistics and other professionals, responsible for the review of new drugs. The medical device review team, which consists of professionals such as clinical medicine, clinical diagnosis, mechanical, electronic, materials and biomedical engineering, is responsible for the evaluation of innovative medical devices. In addition to technology production and other technical secrets, the review conclusions shall be all open to public and accept public supervisions. Unify the Class II medical devices review standards, and gradually achieve unified review standards on a national level.

（二十九）落实相关工作人员保密责任。参与药品医疗器械受理审查、审评审批、检查检验等监管工作的人员，对注册申请人提交的技术秘密和试验数据负有保密义务。违反保密义务的，依法依纪追究责任，处理结果向社会公开；涉嫌犯罪的，移交司法机关追究刑事责任。完善对注册申请材料的管理，确保查阅、复制情况可追溯。

29.  Specify relevant staffs’ confidentiality responsibilities. Those who participate in the supervision and examination, review and approval, inspection of drugs and medical devices and other supervision work, shall have confidential obligations for the applicants’ submitted technical secrets and data. In case of breach of confidentiality obligations, the relevant personnel will be subject to responsibilities according to the laws and disciplines and the result should be disclosed to the public. In case of suspected crime, the relevant personnel should be transferred to the judiciary to pursue their criminal responsibility. Improve the management for registration application materials and ensure that any record of reviewing or copying such materials should be traceable.

（三十）加强审评检查能力建设。将药品医疗器械审评纳入政府购买服务范围，提供规范高效审评服务。加快药品医疗器械审评审批信息化建设，制定注册申请电子提交技术要求，完善电子通用技术文档系统，逐步实现各类注册申请的电子提交和审评审批。建立上市药品医疗器械品种档案。

30.  Strengthen the review and inspection capacity building. Include drugs and medical devices review in the government procurement scope, and provide standardized and efficient review services. Speed up the information infrastructure construction of drugs and medical devices review and approval, establish the electronic registration applications system for technical requirements, improve the electronic general technical documentation system, and gradually realize the electronic submission for various types of registration applications as well as review and approval. Establish the marketed drugs and medical devices catalogue.

（三十一）落实全过程检查责任。药品医疗器械研发过程和药物非临床研究质量管理规范、药物临床试验质量管理规范、医疗器械临床试验质量管理规范执行情况，由国家食品药品监管部门组织检查。药品医疗器械生产过程和生产质量管理规范执行情况，由省级以上食品药品监管部门负责检查。药品医疗器械经营过程和经营质量管理规范执行情况，由市县两级食品药品监管部门负责检查。检查发现问题的，应依法依规查处并及时采取风险控制措施；涉嫌犯罪的，移交司法机关追究刑事责任。推动违法行为处罚到人，检查和处罚结果向社会公开。

31.  Implement the whole process responsibility inspection system. Drugs and medical devices research and development processes and drug non-clinical research quality management practices, drug clinical trial quality management practices, medical devices clinical trial quality management practices, shall be inspected by the national food and drug regulatory authorities. Provincial and higher level food and drug regulatory authorities shall be responsible for the inspection of drugs and medical devices production processes and product quality managements. County and city levels of food and drug regulatory authorities shall be responsible for inspection drugs and medical devices business process and the implementation of quality management standards. Should there be any problems have been found, the illegal behavior shall be checked out and the risk control measures shall be taken subject to the regulations and laws. Any criminal behavior shall be transferred to the judicial and be pursued by means of criminal liabilities. Promote the violation punishment system into individuals, and inspection and punishment results shall be publicly accessible.

（三十二）建设职业化检查员队伍。依托现有资源加快检查员队伍建设，形成以专职检查员为主体、兼职检查员为补充的职业化检查员队伍。实施检查员分级管理制度，强化检查员培训，加强检查装备配备，提升检查能力和水平。

32.  Develop a professional inspector team. Relying on existing resources to speed up the inspector team construction in which full-time inspectors are the main parts and part-time inspectors as a supplement part. Implement the inspector grading management system, strengthen inspectors training sessions, strengthen the inspection devices, and improve the inspection level and capacity.

（三十三）加强国际合作。深化多双边药品医疗器械监管政策与技术交流，积极参与国际规则和标准的制定修订，推动逐步实现审评、检查、检验标准和结果国际共享。

33.  Strengthen the international cooperation. Deepen the multi-national and bilateral drugs medical devices supervision policies and technical exchanges, and actively participate in the development of international rules and standards to promote the progressive realization of the international sharing for review, inspection, inspection standards and results.

六、加强组织实施

VI. Strengthen the Organization and Implementation 

（三十四）加强组织领导。各地区各有关部门要充分认识深化审评审批制度改革鼓励药品医疗器械创新的重要意义，高度重视药品医疗器械审评审批改革和创新工作，将其作为建设创新型国家、促进高科技产业发展的重要内容予以支持，加强统筹协调，细化实施方案，健全工作机制，切实抓好任务落实。坚持运用法治思维和法治方式推进改革，不断完善相关法律法规和制度体系，改革措施涉及法律修改或需要取得相应授权的，按程序提请修改法律或由立法机关授权后实施。

34.  Strengthen the organization and leadership. The relevant departments of various regions shall fully understand the importance of deepening the reform of the review and approval system to encourage the innovation of drugs and medical devices, put a new premium on the importance to reform and innovate the review and approval work of drugs and medical devices examination, treat the approval reform and innovation work as a significant part of building an innovative country which promotes the development of high-tech industries, support and strengthen the co-ordination, refine the implementation of the program, improve the working mechanism, and earnestly implement the task. Persist in a reform process with principles of rule of law, and constantly improve the relevant laws and regulations system, in case a reform measure involves legal changes or prior authorizations, the implementation shall be carried out after correspondent amendment procedures or authorizations have been passed.

（三十五）强化协作配合。充分发挥药品医疗器械审评审批制度改革部际联席会议制度的作用，及时研究解决改革中遇到的矛盾和问题。国家食品药品监管部门要发挥好牵头作用，抓好改革具体实施，协调推进任务落实。各相关部门要依法履职，分工协作，形成改革合力。发展改革部门要支持医药高科技产品的发展，将临床试验机构建设纳入医疗机构建设发展的重要内容。科技部门要加强医药科技发展规划和指导，抓好新药和创新医疗器械研发相关科技计划（专项、基金）的实施。工业和信息化部门要加强医药产业发展规划和指导，强化临床用药生产保障。财政部门要做好药品医疗器械审评审批、检查检验所需经费保障。人力资源社会保障部门要做好医疗保险政策支持新药发展相关工作。卫生计生部门要加强对临床试验机构建设的指导，加强伦理委员会管理和临床试验研究者培训。知识产权部门要做好与专利有关的药品医疗器械知识产权保护工作。中医药管理部门要做好中医药创新工作。

35.  Strengthen cooperation and collaboration. Fully utilize the joint-department conference on the reform of drugs and medical devices approval system, timely research and solve the contradictions and problems encountered in the reform. National food and drug regulatory authorities shall play a leading role, supervise the specific implementation of the reform, coordinate and promote the full implementation of the task. The relevant departments shall perform their duties according to laws, through divisions and cooperation, streamlining a reform force together. The development and reform department shall support high-tech pharmaceutical products’ developments, combine the clinical trial institution constructions as a significant part into the medical institutional construction and development process. The science and technology department shall strengthen the development of medical science and technology planning and guidance, supervise new drugs and innovative medical devices R&D related technology (special project and fund) implementation. The industry and information department shall strengthen the strategical plan guidance of drugs industry and the production of clinical drug protection. Finance department shall conduct drug medical devices review and approval, strengthen and ensure drugs producing funds. The human resources and social security department shall facilitate with medical insurance policy to support the development of new drugs related tasks. The healthcare and family planning department shall strengthen the guidance of clinical trial institutions, strengthen the ethics committee management and researchers training sessions. The intellectual property department shall protect patents and drugs medical devices intellectual property rights appropriately. Traditional Chinese medicine management authority shall support traditional Chinese medicine innovation.

（三十六）做好宣传解释。正面宣传鼓励药品医疗器械创新的重要意义，加强审评审批制度改革重要政策、重大措施解读，及时解答社会各界关注的热点问题，主动回应社会关切，合理引导各方预期，营造改革实施的良好舆论氛围。

36.  Organize publicity and interpretation related work. Emphasize the importance of drugs and medical devices innovation from positive publicity perspective, strengthen the interpretation on major policies and major rules related to the review and approval system reform, promptly answer questions related hot topics in society, proactively respond to social concerns, reasonably guide all parties’ expectations, and create a friendly atmosphere for the implementation of the reform.

感谢阅读