国家药品监督管理局

三氧化二砷（As2O3）于1999年正式通过了国家药品监督管理局的审批，并于2000年9月25日作为治疗急性早幼粒细胞白血病（APL）的新药通过FDA的审批。

Arsenic trioxide ( As_2O_3 ), as an anticancer drug for the treatment of acute promyelocytic leukemia ( APL ), was approved by SDA of China in 1999 and by FDA of USA in 2000.Its mechanisms of chemotherapeutic effects were very complex .

国家药品监督管理局按照本办法予以审查，符合规定的，在专利期满后批准生产或者进口。

The SDA shall make examination pursuant to these Measures , and , if the provisions are met , approve the manufacturing or import after the patent expires .

国家药品监督管理局（SDA）负责药品的行政保护；

The State Drug Administration (" SDA ") was responsible for administrative protection of pharmaceuticals ;

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；

In2005 the State Drug Administration should be invited to participate in the conference final GMP pharmaceutical excipients and medicinal material management practices seminars ;

这对于保证国家药品监督管理局《药品临床试验管理规范（GCP）》的正确实施，充分保障受试者的合法权益，具有十分重要的现实意义。

Ms is of great significance in ensuring the implementation of GCP issued by the National Drug Supervision Administration and protecting tile legal rights of the subjects in the experiments .

国家药品监督管理局北京医疗器械质量监督检验中心

Beijing Center for Medical Device Quality Supervision and Testing of State Drug Administration

经国家药品监督管理局批准，JS016进入一期临床试验。

JS016 entered a phase-1 clinical trial after an approval by the National Medical Products Administration .

临床试用和评估的有关活动必须符合国家药品监督管理局有关文件的规定。

The activities involved in clinic test or evaluation shall BE in conformity of the provisions of the State Drug Administration .

邮局和药店之间有个很不错的干洗店。国家药品监督管理局〔中国〕

And there 's a very nice Laundromat between the post office and the drug store . State Drug Administration [ China ]

国家药品监督管理局已批准该试剂盒，其可在30分钟内出检测结果。

The National Medical Products Administration has issued a certificate for the products , which can generate test results in 30 minutes .

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 .

在1998年国务院机构改革过程中，对我国的药品管理体制进行了很大的调整，成立了国家药品监督管理局。

Viewing the reform of the organization of the State Council in 1998 , the system of the drug administration in China has been greatly changed .

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 .

罕见病、特殊病种及其他情况，要求减少临床研究病例数或者免做临床试验的，必须经国家药品监督管理局审查批准。

As for rare diseases , special diseases or other circumstances where it is needed to reduce clinical study cases or to exempt the clinical trial , examination and approval by the SDA is required .

方法：根据国家药品监督管理局颁布的新药审批办法的规定，取家兔红细胞进行苦参碱葡萄糖注射液溶血性试验；

Method : According to the Examining and Approving Method for New Drug promulgated by the State Supervising and Administering Bureau of Drugs , the rabbit erythrocytes were collected for detecting the haemolytic effects of MGI .

2001年国家药品监督管理局对全国流通领域橡胶避孕套进行了监督抽查，质量状况不容乐观，产品质量有待提高。

The SDA 's selective supervision and examination of rubber condoms in the circulating field all over the country in 2001 show that the product quality is not to be optimized about and should be increased further .

对我国新药法规体系的建立过程进行了系统研究和论述，并指出在国家药品监督管理局成立后，我国新药法规体系的发展将进入新阶段。

The establishment process of China 's legal system for new drugs was reviewed and pointed out that the development in the legal system for new drugs of our country would come into a new stage after the establishment of the State Drug Administration .

所有产品均通过国家食品药品监督管理局GMP认证。

All her products are GMP certified by the State Food and Drug Administration ( SFDA ) .

从加拿大进口的13C鄄尿素试剂已获得国家食品药品监督管理局许可并应用于临床。

13C-labelled urea imported from Canada has been permitted by the State Food and Drug Administration to be used in 13C-UBT in clinic .

该疫苗星期一已经通过国家食品药品监督管理局（SFDA）专家小组的认证，并有望于本周内获得政府批准。

After passing a panel of experts certification organized by the State Food and Drug Administration ( SFDA ) Monday , the vaccine is expected to be approved by the government this week .

一家中国制药公司已得到国家食品药品监督管理局批准，成为国内首家正式生产国产版本万艾可（Viagra）的厂家，万艾可是辉瑞公司（Pfizer）治疗勃起功能障碍的著名药物。

A Chinese pharmaceutical company has received the green light from China 's State Food and Drug Administration to become the country 's first official producer of a homegrown version of Viagra , Pfizer 's famous erectile dysfunction drug .

第Ⅲ类新药黄葵胶囊，不久前已获得国家食品药品监督管理局（SFDA）的审批，主要是由黄蜀葵花的醇提取物组成，广泛用于治疗慢性肾小球肾炎。

' HuangKui Capsule ', mainly composed of A. manihot flower extract , has acquired approval from State Food and Drug Administration ( SFDA ) as class III new drug for treating chronic glomerulonephritis for many years .

我国学者自主创新研发的新型重组人血管内皮抑素（Endostar，恩度），2005年被我国国家食品药品监督管理局批准联合NP方案治疗非小细胞肺癌。

A novel recombinant human endostatin ( endostar ), combined with NP chemotherapy studied by scholars of our country , was approved by the State Food and Drug Administration of China in 2005 for the treatment of non-small - cell lung cancer .

2005年5月25日，经国家食品药品监督管理局（SFDA）批准，丹参多酚酸盐及其注射用丹参多酚酸盐的新药注册申请获得了新药证书和生产批文。

On May 25 , 2005 , a New Drug Application ( NDA ) of depsides salts from Salvia miltiorrhiza and its preparation for the treatment of coronary artery disease had received official approval from State Food and Drug Administration ( SFDA ) .

即对确定请求权、减额请求权、消灭请求权制度作出规定。国家食品药品监督管理局第16号令《医疗器械注册管理办法》释义（三）

Explanation of Regulation for Registration of Medical Device ( SFDA No.16 )( 3 )

2003年，中国国家食品药品监督管理局禁止药店在没有医生处方的情况下销售抗生素。

In2003 , the State Food and Drug Agency banned pharmacies from selling antibiotics without doctors'prescriptions .

由国家食品药品监督管理局与海关总署另行制定。

Shall be separately formulated by the State Food and Drug Administration and the General Administration of customs .

关于国家食品药品监督管理局直接接触药品的包装材料和容器标准汇编中存在的几个问题

Existent Problems in Standard Collection of Packaging Materials and Containers for Direct Contact Medicines Promulgated by State Food and Drug Administration

药材进口备案和口岸检验的规定，由国家食品药品监督管理局另行制定。

The regulations for import record keeping and port inspection shall be separately formulated by the State Food and Drug Administration .

但中国国家食品药品监督管理局不会对我们已经拥有专利的药品发放新药许可。

But the Chinese SFDA will not issue a new drug license for a compound that we already have a patent for .