药品注册、市场、法规、行政类外语学习词汇.docx

of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres h册申请书application pending      
申请待批准approval number     批准文号approved information   批准信息As discussed at the FDA Pre-NDA meeting      
如新药申请前与FDA会议中讨论的那样ASSISTANT COUNSEL      
助理巡视员ASSISTANT MINISTER  部长助理ASSTANT CONSULTANT    
助理调研员
B
"Based on the requirement to ensure public health, SFDA may implement a monitoring period for the approved new drugs so as to continue to monitor the safety of the new drug. The drug-monitoring period shall start from the date of approval for production, and shall not exceed 5 years. For the new drugs under the monitoring period, SFDA shall not approve production, dosage change and importation of the drug by other enterprises."      
国家食品药品监督管理局根据保护公众健康的要求，可以对批准生产的新药品种设立监测期。监测期自新药批准生产之日起计算，最长不得超过5年。监测期内的新药，国家食品药品监督管理局不批准其他企业生产、改变剂型和进口。batch certification      批认证Batch Number (or Lot Number)    
批号batch release      批号发放be chemically described as      
化学名为be involved in one of the steps of the finished product manufacturing      
参与成品生产过程be submitted in typeface      
递交时打印Berhad (BHD)    
 马来西亚语，意为“公司”。在马来西亚，企业一般注册为个人企业、合伙人企业或私人XX，其中以SDN BHD最为常见。除新加坡和文莱（马来语是两国正式语言）企业名称偶尔出现SDN BHD外，其他国家企业名称基本没有SDN BHD字样。BHD单独出现时一般指公众XX。Besloten Vennootshap met beperkte aansprak-elijkhed (.)      
荷兰文,指私人XX。荷兰法律规定，公司的名称可以不是荷兰文，