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中华人民共和国关于《药品数据管理规范》征求意见稿

时间:2018-02-28作者:admin 浏览量:187

通报号: G/TBT/N/CHN/1254
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: 《药品数据管理规范》分总则、质量管理、人员、数据基本要求、系统、附则,适用于药品研制、生产、流通、上市后监测与评价等活动。《规范》对国际上数据管理的通行要求“ALCOA”,用“追溯至人、清晰可溯、同步记录、原始一致、准确真实”20个字概括和表达。
正文: 世界贸易组织G/TBT/N/CHN/12542018-01-1818-0478 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:[X] 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: 《药品数据管理规范》征求意见稿 语言:中文 页数:11 链接网址: 6.内容简述: 《药品数据管理规范》分总则、质量管理、人员、数据基本要求、系统、附则,适用于药品研制、生产、流通、上市后监测与评价等活动。《规范》对国际上数据管理的通行要求“ALCOA”,用“追溯至人、清晰可溯、同步记录、原始一致、准确真实”20个字概括和表达。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 [X], 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: Good Data and Record Management Practices (Draft) (11 page(s), in Chinese)  6.Description of content: Good Data and Record Management Practices (GDRP) include general provisions, quality management, personnel, basic requirements of data, system and supplementary provisions, which is applicable to drug development, manufacture, distribution, post-marketing surveillance and evaluation. The data in GDRP should be complete as well as attributable, legible, contemporaneous, original and accurate, commonly referred to as "ALCOA".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_0436_00_x.pdf


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