摘要
目的为我国药品制剂出口企业ANDA申请过程中有关标签等包装标识物资料申报和规范管理提出建议。方法分析美国有关标签等包装标识物监管的法律法规或指南的特征和意图。结果与结论我国制剂企业在ANDA申请工作中标签等包装标识物存在一些问题,应对照美国的法律法规进行改正。
Objective To give suggestions on submission and management of data relating to labeling and packaging in the ANDA application process for domestic drug manufacturers. Methods To analyze the features and purposes of the American law ＆ regulation or guidance on labeling ＆ packaging. Results and Conclusions Problems exist in the part of labeling and packaging during the process of ANDA submission by Chinese drug manufacturers, and these problems should be addressed by referring to the related American laws and regulations.
出处
《中国药事》
CAS
2009年第9期929-931,共3页
Chinese Pharmaceutical Affairs
