This article is to introduce EMEA's(European Medicines Agency,EMEA)consideration on strategy and design of clinical trials for new antibacterial agent,hoping to give some reference to design and evaluation of clinical trials for new antibacterial agent in China.
本文简要介绍了欧盟医药管理局对抗菌药物临床试验策略和设计的相关考虑,希望对我国创新性抗菌药物的临床试验设计和评价有所提示和参考。
This article is to introduce the CHMP guideline on the clinical investigations of medical products for the treatment of pulmonary arterial hypertension newly released by European Medicines Agency,hoping to give some reference to design and evaluation of clinical trials for pulmonary arterial hypertension agents in China.
欧盟医药管理局的人用医药产品委员会(CHMP)于2008年12月18日,在伦敦发布了作为征求意见草案的CHMP关于治疗肺动脉高压医药产品的临床研究指导原则,旨在为评价新的用于联合治疗肺动脉高压的医疗产品或药物提供指南。
Food and Drug Administration [FDA] [United States]
食物暨药物管理局〔美国〕
Food and Drugs Administration [United States]
食品及药物管理局〔美国〕
Exhibit A is the US Food and Drug Administration.
证据之一是美国食品和药物管理局。
The world's first weight-loss drug for dogs has been approved by the US Food and Drug Administration( FDA).
全球第一种狗狗专用减肥药业经美国食品药物管理局核准。
In all of 2007, the FDA received 100 reports of problems with the drug.
2007全年食品与药物管理局收到100关于这种药品的投诉。
The U. S. Food and Drug administration classifies it as a food additive for tea.
美国食品和药物管理局把它归在茶的辅加食物一类。
Although the Food and Drug Administration (FDA) has tried repeatedly to control these procedures, the practices continue.
虽然食品及药物管理局不断试图制止这种做法，仍无济于事。
The Court generally upheld the FDA's summary judgment practice.
最高法院普遍确认了食品和药物管理局的即决审判作法。
and it's now widely available after gaining approval from the U. S. Food and Drug Administration.
在获得美国食品药物管理局认可后，现在它随处可得。
the Food and Drug Administration negotiates "voluntary" recalls of potentially hazardous food products;
食品和药物管理局协商议定"自愿"撤回有潜在危害的食品产品；
Commercial production and distribution follow the FDA's regulatory approval.
获得食品和药物管理局批准后，便可以进行商业生产和经销。
FDA scientists have been working with firms to investigate the problem.
美国食品及药物管理局已同有关企业对此问题展开调查。
The FDA inspects only 2-3 per cent of all incoming food.
美国食品和药物管理局检查的产品仅占全部入境食品的2%至3%。
International Conference of Drug Regulatory Authorities
药物管制当局国际会议
State Drug Administration (SDA)
国家药品监督管理局
State Administration of Traditional Chinese Medicine [China]
国家中医药管理局〔中国〕
Beijing Drug Administration
北京市药品监督管理局
U.S. Food and Drug Administration(FDA)
美国食品药品管理局