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Opinions of the General Office of the State Council on Reforming and Improving the Policy for Supply Guarantee and Use of Generic Drugs [Effective]
国务院办公厅关于改革完善仿制药供应保障及使用政策的意见 [现行有效]

Opinions of the General Office of the State Council on Reforming and Improving the Policy for Supply Guarantee and Use of Generic Drugs 


(No. 20 [2018] of the General Office of the State Council) (国办发〔2018〕20号)

The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council; and all institutions directly under 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:
For the purposes of implementing the spirit of the 19th CPC National Congress and the work arrangements of the CPC Central Committee and the State Council for advancing the building of a healthy China and the deepening of the medical reform, boosting the research and development of generic drugs, improving the quality and therapeutic effect of generic drugs, enhancing the capabilities of guaranteeing drug supply, better meeting the needs for clinical drugs and public health safety, and accelerating the shift of China from a big pharmaceutical manufacturer to a pharmaceutical manufacturing power, with the approval of the State Council, the following opinions are hereby offered. 为贯彻落实党的十九大精神和党中央、国务院关于推进健康中国建设、深化医改的工作部署,促进仿制药研发,提升仿制药质量疗效,提高药品供应保障能力,更好地满足临床用药及公共卫生安全需求,加快我国由制药大国向制药强国跨越,经国务院同意,现提出如下意见。
I. Furthering the research and development of generic drugs   一、促进仿制药研发
1. Developing catalogs of encouraged generic drugs. An interdepartmental drug manufacturing and use information sharing mechanism shall be established, the information on the supply guarantee and use of drugs shall be enhanced, the information on the supply of and demand for drugs shall be acquired and released in a timely manner, and research and development, registration, and manufacturing by enterprises shall be directed. Oriented to demand, the production of generic drugs necessary for clinical practices, with determinate therapeutic effect, in short supply shall be encouraged, and the production of generic drugs necessary for preventing and treating major infectious diseases and rare diseases, for disposing of breaking public health emergencies, or for children or without a registration application submitted one year before the patent on their brand-name counterpart expires shall be encouraged. The National Health Commission and the State Drug Administration shall develop catalogs of encouraged generic drugs in conjunction with relevant authorities, regularly release the catalogs in the China Drug Supply Information Platform and other relevant platforms, and make dynamic adjustments. A drug whose marketing is newly approved or which is passed in the generic drug quality and therapeutic effect consistency assessments shall be entered in the China Marketed Drugs Catalogs, the content of which shall be dynamically updated and instantaneously released. (一)制定鼓励仿制的药品目录。建立跨部门的药品生产和使用信息共享机制,强化药品供应保障及使用信息监测,及时掌握和发布药品供求情况,引导企业研发、注册和生产。以需求为导向,鼓励仿制临床必需、疗效确切、供应短缺的药品,鼓励仿制重大传染病防治和罕见病治疗所需药品、处置突发公共卫生事件所需药品、儿童使用药品以及专利到期前一年尚没有提出注册申请的药品。鼓励仿制的药品目录由国家卫生健康委员会、国家药品监督管理局会同相关部门制定,定期在国家药品供应保障综合管理信息平台等相关平台发布,并实行动态调整。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,上市药品目录集内容动态更新并实时公开。
2. Strengthening the research on generic drug technology. The research on critical common technology in relation to priority chemical drugs and biopharmaceuticals in the catalogs of encouraged generic drugs shall be included in the relevant national science and technology projects. The medical collaborative innovation mechanism of enterprises, universities and scientific research institutes shall be improved, a generic drug technology research league shall be established, the leading role of enterprises and the basic supporting role of hospitals, scientific research institutes, and institutions of higher learning shall be exploited, the interaction in the research and development of raw materials and auxiliary materials, packaging materials, and preparations for drugs shall be intensified, and the organic connection between the chain of research and development of drugs with the industry chain shall be promoted. Advanced international technology shall be actively introduced, digested, absorbed, and improved. (二)加强仿制药技术攻关。将鼓励仿制的药品目录内的重点化学药品、生物药品关键共性技术研究列入国家相关科技计划。健全产学研医用协同创新机制,建立仿制药技术攻关联盟,发挥企业的主导作用和医院、科研机构、高等院校的基础支撑作用,加强药用原辅料、包装材料和制剂研发联动,促进药品研发链和产业链有机衔接。积极引进国际先进技术,进行消化吸收再提高。
3. Augmenting the protection of intellectual property rights in drugs. According to the principle of paying equal attention to encouraging the development and production of new drugs and the research and development of generic drugs, a regime to protect intellectual property rights in drugs commensurate with the level of China's economic and social development and the phase of industry development shall be researched and refined, and the interests between patentees of drugs and the public shall be sufficiently balanced. The patent quality improvement project shall be implemented to nurture more essential intellectual property rights in drugs, original intellectual property rights, and high-value intellectual property right. The anti-monopoly law enforcement in the intellectual property right field shall be intensified, and while the innovation in drugs are sufficiently protected, the abuse of intellectual property rights shall be prevented, so as to promote the marketing of generic drugs. A patent early warning mechanism in the drug field shall be established and improved to lower the risk that generic drug enterprises infringe on patent. (三)完善药品知识产权保护。按照鼓励新药创制和鼓励仿制药研发并重的原则,研究完善与我国经济社会发展水平和产业发展阶段相适应的药品知识产权保护制度,充分平衡药品专利权人与社会公众的利益。实施专利质量提升工程,培育更多的药品核心知识产权、原始知识产权、高价值知识产权。加强知识产权领域反垄断执法,在充分保护药品创新的同时,防止知识产权滥用,促进仿制药上市。建立完善药品领域专利预警机制,降低仿制药企业专利侵权风险。
II. Heightening the quality and therapeutic effect of generic drugs   二、提升仿制药质量疗效
4. Accelerating the advancement of generic drug quality and therapeutic effect consistency assessments. The State Drug Administration, the National Health Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, and the State Medical Insurance Administration, and other authorities shall detail and implement the policies and measures for encouraging enterprises to assess the consistency of the quality and therapeutic effect of generic drugs and accelerate the advancement of consistency assessments. The consistency assessment resources for generic drugs shall be further released, and medical institutions, institutions of higher learning, scientific research institutes, and social inspection and testing institutions with good conditions shall be supported in participating in consistency assessments. Effective measures shall be taken to improve the motives of medical institutions and medical staff to conduct clinical trials. For drugs clinically much in demand and representing a relatively high proportion in terms of value, relevant authorities shall speed up the work progress; and for drugs clinically necessary and cheap, relevant authorities shall take pertinent measures and provide support by improving procurement and use policies and other means. (四)加快推进仿制药质量和疗效一致性评价工作。国家药品监督管理局、国家卫生健康委员会、科学技术部、工业和信息化部、国家医疗保障局等部门要细化落实鼓励企业开展仿制药质量和疗效一致性评价的政策措施,加快推进一致性评价工作。进一步释放仿制药一致性评价资源,支持具备条件的医疗机构、高等院校、科研机构和社会办检验检测机构参与一致性评价工作。采取有效措施,提高医疗机构和医务人员开展临床试验的积极性。对临床使用量大、金额占比高的品种,有关部门要加快工作进度;对临床必需、价格低廉的品种,有关部门要采取针对性措施,通过完善采购使用政策等方式给予支持。
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