已有国家标准药品的申请，是指生产已经由国家药品监督管理局颁布的正式标准的药品注册申请。
Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA has promulgated official standards.
药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.
遇有特殊情况的，经国家药品监督管理局批准，可以适当延长。
In case of special circumstances, the time period may be appropriately extended upon the approval by the SDA.
第二十三条药物临床前研究应当参照国家药品监督管理局发布的有关技术指导原则进行。
Article 23 Investigational study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SDA.
有质量检测中心、验收养护室、中药标本室，目前已通过国家药品监督管理局《药品经营质量管理规范》验收。
Quality Inspection Center, room acceptance conservation, medicine specimen room, has passed a State Drug Authority "medicine quality control" acceptance.
有质量检测中心、验收养护室、中药标本室，目前已通过国家药品监督管理局《药品经营质量管理规范》(GSP)验收。
Quality Inspection Center, room acceptance conservation, medicine specimen room, has passed a State Drug Authority "medicine quality control" (GSP) acceptance.
2005年应国家药品监督管理局邀请，参与了药用辅料GMP定稿工作会议和药用辅料管理办法的讨论会；
In 2005 the State Drug Administration should be invited to participate in the conference final GMP pharmaceutical excipients and medicinal material management practices seminars;
1998年国家药品监督管理局成立后，建立了国家药品监督管理局药品认证管理中心。
In 1998, after the establishment of the state drug administration, establish the state drug administration authentication management center of drugs.
1998年国家药品监督管理局成立后，建立了国家药品监督管理局药品认证管理中心。
In 1998, after the establishment of the state drug administration, establish the state drug administration authentication management center of drugs.
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