>>>welcome visitor, haven't logged in. Login
Subscribe Now Contact us  
Font Size:  A A A Search “Fabao” Window English 中文 = 简体  繁体
  Favorite   DownLoad   Print
 
Notice of the National Health Commission, the National Development and Reform Commission, the Ministry of Education, and Other Departments on Accelerating the Implementation of the Work Plan for Supply Guarantee and Use Polices of Generic Drugs [Effective]
国家卫生健康委、国家发展改革委、教育部等关于印发加快落实仿制药供应保障及使用政策工作方案的通知 [现行有效]
【法宝引证码】

Notice of the National Health Commission, the National Development and Reform Commission, the Ministry of Education, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Finance, the State Administration for Market Regulation, the State Medical Insurance Administration, the State Administration of Traditional Chinese Medicine, the National Medical Products Administration, the National Intellectual Property Administration, and the Supreme People's Court on Accelerating the Implementation of the Work Plan for Supply Guarantee and Use Polices of Generic Drugs 

国家卫生健康委、国家发展改革委、教育部、科技部、工业和信息化部、财政部、市场监管总局、国家医保局、国家中医药局、国家药监局、国家知识产权局、最高人民法院关于印发加快落实仿制药供应保障及使用政策工作方案的通知

(No. 53 [2018] of the National Health Commission) (国卫体改发〔2018〕53号)

The health commissions (health and family planning commissions), development and reform commissions, education departments (education commissions), departments (commissions, bureaus) of science and technology, competent departments of industry and information technology, departments (bureaus) of finance, market regulation bureaus, medical insurance bureaus, administrations of traditional Chinese medicine, medical products administrations, intellectual property administrations, and higher people's courts of all provinces, autonomous regions, municipalities directly under the Central Government, and Xinjiang Production and Construction Corps: 各省、自治区、直辖市及新疆生产建设兵团卫生健康委(卫生计生委)、发展改革委、教育厅(教委)、科技厅(科委)、工业和信息化主管部门、财政厅(局)、市场监管局、医保局、中医药局、药监局、知识产权局、高级人民法院:
In April 2018, the General Office of the State Council issued the Opinions on Reforming and Improving the Policy for Supply Guarantee and Use of Generic Drugs (No. 20 [2018], General Office, State Council). In order to ensure that the decisions and arrangements of the CPC Central Committee and the State Council are effectively implemented and produce effects, the Work Plan for Accelerating the Implementation of the Policy for Supply Guarantee and Use of Generic Drugs is hereby developed and issued to you for your conscientious implementation. 2018年4月,国务院办公厅印发了《关于改革完善仿制药供应保障及使用政策的意见》(国办发〔2018〕20号)。为确保党中央、国务院决策部署落地见效,我们制定了《关于加快落实仿制药供应保障及使用政策工作方案》。现印发给你们,请认真贯彻执行。
National Health Commission 国家卫生健康委
National Development and Reform Commission 国家发展改革委
Ministry of Education 教育部
Ministry of Science and Technology 科技部
Ministry of Industry and Information Technology 工业和信息化部
Ministry of Finance 财政部
State Administration for Market Regulation 市场监管总局
State Medical Insurance Administration 国家医保局
State Administration of Traditional Chinese Medicine 国家中医药局
National Medical Products Administration 国家药监局
National Intellectual Property Administration 国家知识产权局
Supreme People's Court 最高人民法院
December 18, 2018 2018年12月18日
Work Plan for Accelerating the Implementation of the Policy for Supply Guarantee and Use of Generic Drugs 关于加快落实仿制药供应保障及使用政策工作方案
In order to further improve China's capability of supply guarantee of generic drugs, accelerate the advancement of implementation and effects of the 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], General Office, State Council), and better satisfy the people's demands for high-quality generic drugs, this Work Plan is hereby developed. 为进一步提高我国仿制药供应保障能力,加快推进《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》(国办发〔2018〕20号)落地见效,更好地满足人民群众对高质量仿制药的需求,特制定本工作方案。
I. Specifying Key Tasks   一、明确重点任务
1. The catalogue of encouraged generic drugs shall be issued in a timely manner. According to the clinical medication demands, before the end of June 2019, the catalogue of the first batch of encouraged generic drugs shall be issued for the purpose of guiding the R&D, registration, and manufacturing of enterprises. From 2020, the catalogue of encouraged generic drugs shall be issued before the end of each year. (The National Health Commission, the National Medical Products Administration, and the Ministry of Industry and Information Technology shall be responsible and the entity in the first place shall take the lead, same below). (一)及时发布鼓励仿制的药品目录。根据临床用药需求,2019年6月底前,发布第一批鼓励仿制的药品目录,引导企业研发、注册和生产。2020年起,每年年底前发布鼓励仿制的药品目录。(国家卫生健康委、国家药监局、工业和信息化部负责,排第一位的为牵头单位,下同)
2. The science and technology research of generic drugs shall be strengthened. The supporting technologies restricting the industrial development of generic drugs (including R&D of key technologies for generics, improvement and transformation of preparation technologies, and development of raw ingredients and packaging materials) and the R&D of drugs that are clinically required and have no generic ones and their preparations in China shall be included in the relevant national science and technology programs for striving to make technological breakthroughs. After the issuance of the catalogue of encouraged generic drugs, the research of key and common technologies for major chemical drugs and biotech drugs within the catalogue shall be included in the relevant national science and technology programs in a timely manner. The plan for science and technology research of generic drugs (2019-2023) shall be researched and developed. when conditions permit, such plan shall be submitted to the inter-ministerial joint meeting of national science and technology plan management for deliberation as soon as possible. (The Ministry of Science and Technology, the National Health Commission, the Ministry of Finance, the National Development and Reform Commission, the National Medical Products Administration, the Ministry of Industry and Information Technology, and the Ministry of Education shall be responsible.) “Major generic drugs” shall be included in the special and key support to enhancing the core competitiveness of the manufacturing industry and technological transformation within the central budgets and the action plan (2018-2020) shall be developed. (The National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Health Commission, the Ministry of Science and Technology, the Ministry of Finance, and the National Medical Products Administration shall be responsible.)
......
 (二)加强仿制药技术攻关。将制约仿制药产业发展的支撑技术(包括药品仿制关键技术研发、制剂工艺提升改造、原辅料及包装材料研制等)和临床必需、国内尚无仿制的药品及其制剂研发列入国家相关科技计划,进行科技攻关。鼓励仿制的药品目录出台后,及时将目录内重点化学药品、生物药品关键共性技术研究列入国家相关科技计划。研究制定2019-2023年仿制药科技攻关计划,条件成熟时,抓紧报国家科技计划管理部际联席会议审议(科技部、国家卫生健康委、财政部、国家发展改革委、国家药监局、工业和信息化部、教育部负责)。将“重大仿制药物”列为中央预算内增强制造业核心竞争力和技术改造专项重点支持方向,制定2018-2020年行动计划。(国家发展改革委、工业和信息化部、国家卫生健康委、科技部、财政部、国家药监局负责)
......

Dear visitor, as a premium member of this database, you will get complete access to all content.Please go premium and get more.

1. To become a premium member, please call 400-810-8266 Ext. 171.

2. Binding to the account with access to this database.

3. Apply for a trial account.

4. To get instant access to a document, you can Pay Amount 【¥300.00】 for your single purchase.
 
您好:您现在要进入的是北大法宝英文库会员专区。
如您是我们英文用户可直接 登录,进入会员专区查询您所需要的信息;如您还不是我们 的英文用户;您可通过网上支付进行单篇购买,支付成功后即可立即查看本篇内容。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail:info@chinalawinfo.com
     
     
Scan QR Code and Read on Mobile
【法宝引证码】        北大法宝en.pkulaw.cn
Message: Please kindly comment on the present translation.
 
Confirmation Code:
Click image to reset code
 
  Translations are by lawinfochina.com, and we retain exclusive copyright over content found on our website except for content we publish as authorized by respective copyright owners or content that is publicly available from government sources.

Due to differences in language, legal systems, and culture, English translations of Chinese law are for reference purposes only. Please use the official Chinese-language versions as the final authority. Lawinfochina.com and its staff will not be directly or indirectly liable for use of materials found on this website.

We welcome your comments and suggestions, which assist us in continuing to improve the quality of our materials as we dynamically expand content.
 
Home | About us | Disclaimer | Chinese