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中华人民共和国关于《原料药、药用辅料及药包材与药品制剂共同审评审批管理办法(征求意见稿)》

时间:2018-02-28作者:admin 浏览量:138

通报号: G/TBT/N/CHN/1253
ICS号: 11.120.10
发布日期: 2018-01-18
截至日期: 2018-03-19
通报成员: 中华人民共和国
目标和理由: 保护人类安全和健康
内容概述: 为建立以药品上市许可持有人为责任主体的药品质量管理体系,提高药品注册质量和效率,保证药品的安全性、有效性和质量可控性,制订本办法。本办法按照原料药、药用辅料及药包材与药品制剂共同审评审批管理流程分为总则、责任与义务、原辅包登记、原辅包与制剂共同审评审批、变更和终止、监督管理、附则等七章。
正文: 世界贸易组织G/TBT/N/CHN/12532018-01-1818-0477 技术性贸易壁垒原文:英文 通 报



以下通报根据TBT协定第10.6条分发

1.通报成员: 中国 如可能,列出涉及的地方政府名称 ( 3.2条和7.2 条):2.负责机构: 国家食品药品监督管理总局3.通报依据条款:[ ] 2.9.2[ ] 2.10.1[X] 5.6.2[ ] 5.7.1通报依据的条款其他:4.覆盖的产品: 药品 HS编码:30   ICS编码:11.120.105.通报标题: 《原料药、药用辅料及药包材与药品制剂共同审评审批管理办法(征求意见稿)》 语言:中文 页数:10 链接网址: 6.内容简述: 为建立以药品上市许可持有人为责任主体的药品质量管理体系,提高药品注册质量和效率,保证药品的安全性、有效性和质量可控性,制订本办法。本办法按照原料药、药用辅料及药包材与药品制剂共同审评审批管理流程分为总则、责任与义务、原辅包登记、原辅包与制剂共同审评审批、变更和终止、监督管理、附则等七章。7.目标与理由:防止欺诈,保护消费者利益[ ] 保护人类健康和安全[X ] 保护动物或植物的生命和安全[ ] 保护环境[ ] 质量要求[ ] 消费者信息,标签 [ ] 与国际标准协调 [ ] 减少贸易壁垒,促进贸易 [ ] 未指明 [ ] 其他 [ ]8.相关文件:9.拟批准日期:待定拟生效日期:待定10.意见反馈截止日期: WTO秘书处分发后60天11.文本可从以下机构得到:[ ] 国家通报机构[ ] 国家咨询点,或其他机构的联系地址、传真及电子邮件地址(如能提供):中国WTO/TBT国家通报咨询中心电话: +86 10 84603881 / 84603950 传真: +86 10 84603811 电子信箱: tbt@aqsiq.gov.cn
正文(英): 

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.Notifying Member: CHINAIf applicable, name of local government involved (Article 3.2 and 7.2):2.Agency responsible: China Food and Drug AdministrationName and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:3.Notified under Article 2.9.2 [  ], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], other:4.Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Drugs ICS: 11.120.10  HS: 305.Title, number of pages and language(s) of the notified document: Measures for Review and Approval of Drug Master File (DMF) in Support of Finished Drug Product Application (Draft) (10 page(s), in Chinese)  6.Description of content: These measures are formulated to establish a drug quality management system in which marketing authorization holder is the first responsible person, to improve the quality and efficiency of drug registration, and to ensure the safety, effectiveness and quality of drug. Based on management process for review and approval of drug master file (DMF) in support of finished drug product application, these measures consist of seven parts, respectively,General Provisions, Responsibilities and Obligations, DMF Listing, Review and Approval of DMF in Support of Finished Drug Product Application, Alteration and Termination, Supervision and Management, Supplementary Articles.7.Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety8.Relevant documents: -9.Proposed date of adoption: To be determinedProposed date of entry into force: To be determined10.Final date for comments: 60 days from notification11.Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:WTO/TBT National Notification and Enquiry Center of the People's Republic of ChinaTel.: +86 10 84603881/84603950Fax: +86 10 84603811E-mail: tbt@aqsiq.gov.cnhttps://members.wto.org/crnattachments/2018/TBT/CHN/18_0435_00_x.pdf


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