凯茵化工讯 10月8日，中共中央办公厅和国务院办公厅联合印发《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》(以下简称《意见》)。这是继2015年8月《国务院关于改革药品医疗器械审评审批制度的意见》之后，又一个深化药品医疗器械审评审批制度改革的纲领性文件。

　　国家食品药品监督管理总局表示，目前鼓励药品医疗器械创新具备诸多有利条件。一是国内医药创新风起云涌。近年来，我国医药企业新药和创新医疗器械申报数量逐年增加。埃克替尼、阿帕替尼、西达本胺、康柏西普等15个1类创新药获得批准生产，29个创新医疗器械获准上市。我国自主研发的利培酮缓释微球、康柏西普眼用注射液等一批国产药品在美欧发达国家申请注册进入国际市场;经皮介入人工心脏瓣膜系统、乳腺X射线数字化体层摄影设备、植入式迷走神经刺激脉冲发生器等等创新医疗器械达到了国际优良水平。二是审评审批制度改革进展顺利。2015年开始的药品医疗器械审评审批制度改革，提高了审评质量和标准，整治了科研造假不良风气，提高了审评审批透明度。药品审评积压问题如期解决;三是仿制药质量和疗效一致性评价顺利起步。2016年2月，国务院专门发文明确相关政策，部分地方政府也出台相关支持政策，企业参与一致性评价的积极性很高，近期将有一批仿制药率先获准通过;四是上市许可持有人制度十省市试点进展顺利，激发了科研人员创新的热情。

　　《意见》针对当前药品医疗器械创新面临的突出问题，着眼长远制度建设，提出改革临床试验管理、加快上市审评审批、促进药品医疗器械创新和仿制药发展、加强药品医疗器械全生命周期管理、提升技术支撑能力加强组织实施6部分共36项改革措施。

　　针对临床研究资源短缺的问题，《意见》提出临床试验机构资格认定改为备案管理。支持临床试验机构和人员开展临床试验。

　　为满足临床急需药品医疗器械使用需求，《欧利隆碳黑（原）意见》提出加快临床急需药品医疗器械审评审批，允许可附带条件批准上市，上市后按要求开展补充研究。

　　为提升罕见病患者用药品医疗器械可及性，《意见》支持罕见病治疗药品医疗器械研发，对境外已批准上市的有关药品医疗器械，可附带条件批准上市。

　　为进一步推动仿制药质量和疗效一致性评价，《意见》明确建立中国上市药品目录集，注明药品各类信息。

　　同时，《意见》提出探索建立药品审评审批与药品 链接制度、 期限补偿制度、临床数据保护制度等一系列改革“组合拳”。并明确推动上市许可持有人制度全面实施，上市许可持有人对药品医疗器械研发、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。要求完善技术审评体系和制度，加强审评检查能力建设，建设职业化检查员队伍。

In the Office of the State Council issued an opinion to encourage medical equipment innovation

Kailin Chemical News On October 8, the CPC Central Committee General Office and the General Office of the State Council jointly issued the Opinions on Deepening the Innovation of Examination and Approval System for Drugs and Encouraging Innovative Medical Devices (hereinafter referred to as the Opinions). This is yet another programmatic document to deepen the reform of the medical examination and approval system for pharmaceuticals and medical devices following the "State Council's Opinion on Reforming the Examination and Approval System for Medical and Pharmaceutical Devices" in August 2015.

According to the State Food and Drug Administration, there are many favorable conditions for encouraging the innovation of pharmaceutical medical devices at present. First, surging domestic pharmaceutical innovation. In recent years, the number of new drugs and innovative medical devices declared by medical enterprises in our country has been increasing year by year. 15 Class I innovative drugs such as imatinib, apatinib, cedarbamine and compstatin have been approved for production and 29 innovative medical devices have been approved for release. China's independent research and development of risperidone sustained-release microspheres, ophthalmic injection of Compaq Xi Pu and a number of domestic drugs in the United States and Europe developed countries to apply for registration to enter the international market; percutaneous interventional prosthetic heart valve system, digital mammography X-ray Photographic equipment, implanted vagus nerve stimulation pulse generator, etc. Innovative medical equipment has reached the international advanced level. Second, reform of the examination and approval system is proceeding smoothly. The reform of examination and approval system for medical devices beginning in 2015 improved the quality and standard of review, rectified the bad habits of scientific research and fraud, and improved the transparency of examination and approval. The backlog of drug reviews as scheduled solution; Third, the consistency of generic quality evaluation of efficacy and efficacy of a smooth start. In February 2016, the State Council issued a document specifically related to the relevant policies, and some local governments also introduced relevant supportive policies. The enthusiasm for enterprises to participate in the consistency assessment is high. In the near future, a batch of generic drugs will be the first to be approved. Fourthly, Pilot provinces and municipalities progressing smoothly, stimulating the enthusiasm of researchers innovation. In view of the outstanding problems facing the current medical device innovation in medicine, we should focus on the long-term system construction, put forward the reform of clinical trial management, expedite the review and approval of listing review, promote the innovation of pharmaceutical medical devices and the development of generic drugs, and strengthen the medical and pharmaceutical Instrument life cycle management to enhance the technical support capacity to strengthen the organization and implementation of 6 parts a total of 36 reform measures.

In view of the shortage of resources for clinical research, the Opinion proposes that the qualification of clinical trial institutions should be changed to record management. Support clinical trial institutions and personnel to carry out clinical trials.

In order to meet the needs of medical devices urgently needed for clinical use, the Opinion proposes to speed up the examination and approval of medical devices urgently needed for clinical applications, allow listing approval after the listing conditions are available, and supplement the research as required after listing.

To improve the accessibility of medical devices for rare diseases, the Opinion supports the development of medical devices for rare diseases and remedies, and may approve the listing of relevant medical and pharmaceutical devices that have been approved for listing outside the country.

To further promote the consistency of generic drug quality and efficacy evaluation, "Opinions" clearly set the list of Chinese listed drugs, indicating all kinds of drug information.

In the meantime, the Opinion proposed to explore and establish a series of reforms on the examination and approval of drug products, linkage of drug patents, the compensation period of patent deadlines, the system of clinical data protection, and the like. And explicitly promote the full implementation of the system of listed licensees. The holder of the listing license shall bear all legal liabilities for the research and development of pharmaceutical medical devices, clinical trials, manufacturing, sales and distribution, and adverse reaction reports. It is required to improve the system and system of technical review, strengthen the construction of evaluation and inspection capabilities and establish a contingent of professional inspectors.