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- For an overseas applicant, its work office stationed in China or an agency within China commissioned by it shall make the drug registration for it. 境外申请人办理进口药品注册,应当由其驻中国境内的办事机构或者由其委托的中国境内代理机构办理。
- RESULTS: Indian pharmaceutical industry was well ahead of its Chinese counterpart in new drug registration, quality certification, and human resource etc. 结果:印度制药产业在国际新药注册、质量认证和人才战略等方面远远领先于我国。
- METHODS:Based on the requirements on drug registration in Europe and the USA,we expounded the validation on analytical procedures and put forward some concrete methods. 方法:结合欧美原料药注册管理的要求,对其中的分析方法验证部分进行全面阐述,并提出具体的操作方法。
- FDA maintains the repository of NDC numbers in its Drug Registration and Listing System (DRLS) and publishes an extract of this information in its NDC Directory. FDA管理药品注册和备案系统的药品代码数据库并在药品代码目录中发布摘录信息。
- Results and Conclusions EMEA's Drug registration system is more flexible,but there are also some problems in it,such as the centralized procedure is a bit rigid etc. 结果与结论EMEA审评体系较为便利灵活,但也存在中央程序僵化、管理资源重复浪费等问题。
- Results showed that the total content of detectable components in Ganshuang Capsule is more than 50%, which meet the requirements of the V class of new Chinese drugs according to the State Act for Drug Registration. 经检测,肝爽胶囊有效部位可测成分含量达50%25以上,符合中药五类新药的要求。
- RESULTS &CONCLUSION The countermeasures of regulating drug registration management system and relative rules,strengthening policy guidance,and encouraging drug innovation were suggested. 结果和结论完善药品注册管理体系和法律法规的建设,加强政策引导,鼓励新药的自主创新。
- General procedure of the new drugs registration in FDA 美国新药一般的注册程序
- The nurse diluted the drug with saline water. 护士用生理盐水把药加以稀释。
- The druggist put in a full stock of drugs. 那位药商进了一大批药品。
- Do you know the impressive seizures of drugs? 你知道那件轰动一时的毒品扣押案吗?
- Many a famous pop star has been ruined by drugs. 很多著名的流行音乐歌星都因使用毒品而毁了自己。
- We are testing the efficacy of a new drug. 我们正在测试新药的功效。
- I am surprised to learn that he is taking drug. 听说他在吸毒,我很吃惊。
- I'm in trouble with the police over drugs. 我因毒品事落入警方手中。
- He was found in possession of dangerous drugs. 她被发现藏有危险物品。
- She went to prison for peddling drugs. 她因贩卖毒品而入狱。
- The man formed a habit of taking harmful drugs. 这人养成了服用有害麻醉品的习惯。
- His business was a cover for drug dealing. 他的商行是进行毒品交易的幌子。
- She took drugs to dull the pain. 她吃了药以减轻疼痛。