单词 | 食品药品监督局 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
释义 | 食品药品监督局 —state food and drug administration (SDA)See also:药监局—State Food and Drug Administration (SFDA)
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美国艾尔建 (Allergan) 公司生产的肉毒素和产自瑞典Q-med公司的瑞蓝(Restylane)玻尿酸于2009年刚刚获得国 家 食 品 药品监督局 核 准。 beijing.ufh.com.cn | Allergan’s Cosmetic Botox and Q-Med’s Restylane were approved for use in China in 2009. shanghai.ufh.com.cn |
在短短的两三年时间内,嘉和公司已经在几个关键业务上取得了重要进展:2011年 [...] 2月,嘉和公司与一家全球500强跨国制药企业签订了第一份国际医药制造外包(CMO)业务合同;2011年5月,公司第一个生物仿制药GB221项目向国 家 食 品 药品监督 管 理 局申报临床批件,并通过上 海 食 品 药品监督局 的 现 场核查;GB221在澳大利亚的国际I期临床试验也已顺利完成。 wison.com | In May 2011, Genor finished IND filing [...] of the first biosimilar GB221 for approval of SFDA and passed the on-site verification of the Shanghai Food and Drug Administration. wison.com |
十届全国政协副主席张怀西、国家食 品 药品监督局 、 国 家发改委相关领导、江苏省省长助理徐南平、无锡市市长朱克江等政府领导出席了活动开幕仪式并致辞,他们表示,生物产业是高科技朝阳产业、“十二五”战略性新兴产业,无锡抗体高峰论坛的召开契合了当前国家的经济和科技发展趋势,为加强国际学术交流合作搭建了一个理想平台;同时希望药明康德能够以无锡研发生产基地投运为契机再创辉煌。 wuxiapptec.com.cn | Attending the opening ceremony were former vice chairman of Chinese People's Political Consultative Conference (CPPCC), Mr. Zhang Huaixi; officials from State Food and Drug Administration (SFDA) and the National Development and Reform Commission (NDRC); the assistant of Jiangsu governor, Mr. Xu Nanping; mayor of Wuxi, Mr. Zhu Kejiang and other government officials. wuxiapptec.com |
美国批准的通用型药物 食品药品监督管理局(FDA)... malvern.com.cn | Generic drugs [...] approved by the U.S. Food and Drug Administration (FDA)... malvern.de |
这些病人用药后产生疼痛、红眼病、视力模糊等多种副作用,引起了国 家 食 品 药品监督 管 理 局 ( SF DA)的调查和全国媒体的广泛关注。 beijing.ufh.com.cn | These patients developed various side effects including pain, red eyes, [...] and unclear vision [...] after taking the drug, sparking an investigation by China’s State Food and Drug Administration (SFDA) and widespread [...]interest from national media. beijing.ufh.com.cn |
而今,国家食品药品监督管理局强令每批次疫苗在进入市场前都要通过严格的测试。 beijing.ufh.com.cn | Now, the Chinese State Food and Drug Administration (SFDA) mandates [...] that each single batch of vaccine has to pass rigorous [...]testing before being released into the market. beijing.ufh.com.cn |
2001年,美国食品药品监督管理局(FDA) 同意我们的顾客向市场推出适用于2岁以上艾滋病患者的抗逆转录病毒药物以及其他抗逆转录病毒药物。 cellmark.com | By 2001, [...] our customer received FDA approval to market the antiretroviral drug for the treatment [...]of HIV infection in patients [...]2 years of age and older, in combination with other antiretroviral drugs. cellmark.com |
今天宣布,美国食品药品监督管理局 ( FDA)已批准该公司用于治疗 II型糖尿病的同类首创激酶活化剂MLR-1023的新药临床试验申请(IND)。 businesswirechina.com | (BUSINESS WIRE)--Melior Discovery, Inc. today announced that the United States Food and Drug Administration (FDA) has approved [...] its Investigational [...]New Drug (IND) application for the clinical development of its novel first-in-class kinase activator, MLR-1023, for the treatment of Type II diabetes. businesswirechina.com |
对于亚洲肤色和质地,我们的elos技术提供了被证明是安全有效的治疗方法,这使得我们的产品在中国市场成为理想的选择,同时我们很高兴最近获得了国 家 食 品 药品监督 管 理 局 的 审 批。 tipschina.gov.cn | Our elos technology provides proven safe and efficacious [...] treatments for Asian skin tone [...] and texture, making our products ideal for the Chinese [...]market, and we are thrilled with these recent SFDA clearances. tipschina.gov.cn |
公司融汇了国内外先进的制管工艺技术,引进了先进的全自动铝软管生产线,产品生产过程及质量控制完全符合国 家 食 品 药品监督 管 理 局 发 布 的国家标准YBB00162002《铝质药用软膏管》,及代表目前世界软管水平并被国际同行普遍认同的英国标准BS2006的要求,并配备齐全上述标准规定的所有理化及卫生学检测设备和手段。 shenglitube.com | Pipe company integrates advanced technology at home and abroad, the introduction of advanced automatic aluminum tube production lines, production process and quality [...] control is completely in [...] line with the state Food and Drug Administration issued national [...]standards YBB00162002< aluminum tube medicinal ointment " Hose level surrounded [...]by representatives of the world and their international counterparts generally accepted requirements of British Standard BS2006. fully equipped with all the above criteria and the physical and chemical detection equipment and the means and health. shenglitube.com |
于2005 年2月通过国家食品药品监督管理局的 检 查,取得《药品包装用材料容器生产许可证(I类)》证书(国药包字20050179)。 shenglitube.com | In February [...] 2005 by the State Food and Drug Administration inspection [...]made the "drug packaging materials container production [...]license (I)" Certificate (next-packet character 20050179). shenglitube.com |
Politico (10/13, [...] Haberkorn)报道,“一个两党联立的众议院能源及商业委员会成员小组要 求 食 品 及 药品监督局 能 够推迟一些由它所提议针对一系列医疗器械审查及批准程序的修改。 uschie.org | Politico (10/13, Haberkorn) reports, "A bipartisan group of House [...] Energy and Commerce Committee [...] members wants the Food and Drug Administration to delay some of [...]its proposed changes to the [...]process of reviewing and approving a wide array of medical devices. uschie.org |
我们对受美国食品药品监督管理局( FDA)、欧盟委员会(EU)及其成员国机构以及全球类似机构管制的多种行业之产品进行推广、提供保障和支持。 khlaw.com | We promote, [...] protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European [...]Commission and Member [...]States authorities in the European Union (EU) and similar authorities throughout the world. khlaw.com |
由国会于1938年通过,FDCA是授权美国食品 和 药品监督 管 理 局 对 食 品 , 药品和化妆品的安全和有效性进行监督的一系列法律。 wipo.int | Originally passed by Congress in 1938, [...] the FDCA is a set of [...] laws giving authority to the U.S. Food and Drug Administration to oversee the safety and efficacy of food, drugs, and cosmetics. wipo.int |
该公司的第一个产品是Sensei 机器人导管系统,于2007年5月经美国 食 品 药品监督 管 理 局 ( FDA)批准用于电生理(EP)手术中特定标测导管的操作和控制。 tipschina.gov.cn | Its first product, the Sensei Robotic Catheter system, was cleared by the U.S. Food and Drug Administration (FDA) in May 2007 for manipulation and control of certain mapping catheters [...] in electrophysiology (EP) procedures. tipschina.gov.cn |
Koning目前正在申请美国食品药品管理局(FDA)认证、中国国 家 食 品 药品监督 管 理 局 ( S F DA )认证和加拿大的医疗设备许可证。 china.hospimedica.com | Koning is [...] currently seeking US Food and Drug Administration (FDA) approval in the United States, State Food and Drug Administration (SFDA) approval [...]in China, and [...]Canada Medical Device License. hospimedica.com |
我们提供解决方案的人员充分了解您的监管环境,并理解一些塑料和橡胶材料必须满足美 国 食 品 药品监督 管 理 局 ( FDA)和美国国家卫生基金会(NSF)的要求。 elastoproxy.com | Our solutions providers understand your regulatory environment, and how some plastic and rubber [...] materials must meet [...] requirements from the U.S. Food and Drug Administration (FDA) and the National [...]Sanitary Foundation (NSF). elastoproxy.com |
该产品的有效性和安全性得到保证,美 国 食 品 药品监督 管 理 局 ( F D A)和欧洲权威机构也在2008年批准其用于12岁以上患者慢性乙肝病毒的治疗。 cellmark.com | The effectiveness and safety profile of this product were so [...] strong, the FDA and European authorities also approved [...]it for chronic hepatitis [...]B virus in patients 12 years of age and older in 2008. cellmark.com |
在今后的 18 个月,Sundise 公司将在美国7家研究单位开展有 [...] 100 例受试者参与的Ⅱ期临床研究,并随后开展Ⅲ期试验,最终向美 国 食 品 药品监督 管 理局 (FDA) 递交上市申请。 mdsol.com | While this cutting-edge drug for liver fibrosis has been approved by the China State Food and Drug Administration (SFDA), marketed and in use in China since 2003, Sundise will conduct a 100-subject, seven-site Phase II study in the U.S. [...] over the next 18 months to move towards subsequent Phase III trials [...] and then ultimately, submission for U.S. FDA approval. mdsol.com |
DIAGAST(迪卡斯)将为您隆重展出全自动血型分析仪,手工检测液体试剂,贴牌生产产品系列,还有奥利巴斯全自动系统配套系列试剂,我们已经取得中国大陆国 家 食 品 药品监督 管 理 局 注 册文号的单克隆Anti-D试剂,我们新型应用红细胞磁化技术的微孔板等等。 diagast.com | DIAGAST Team will be glad to present you its automated, [...] manual and OEM ranges of product as the PK ranges for Beckman [...]PK automated systems, our SFDA [...]registered monoclonal anti-D, our new microplate configurations using E.M. Technology and many others. diagast.com |
嘉法狮已经在美国食品药品监督管理 局 注 册 了IV类DMF,在加拿大卫生部注册了III类DMF。 gattefosse.com | Gattefossé has registered Type IV [...] DMFs with the US Food & Drug Administration and Type III [...]DMFs with Health Canada. gattefosse.com |
所有医疗设备必须在国家食品 药品监督 管 理 局 ( SF DA)进行登记,我们将很高兴协助您完成这两项注册。 tuv.com | All medical devices must be [...] registered with the State Food and Drug Administration (SFDA). tuv.com |
典范医疗位于上海张江高科技产业园东区现代医疗器械园,拥有Ⅲ类无菌医疗器械产品的生产资质,建立了完善的生产质量管理体系,通过了上海 市 食 品 药品监督 管 理 局 根 据 国家《医疗器械生产质量管理规范――无菌医疗器械实施细则》及ISO13485:2003组织的质量体系考核。 divine-med.com | Divine Medical is located in the Eastern medical equipment park of Zhangjiang High-Tech Industrial Park in Shanghai, has the production qualification of class III sterile medical equipments, has established complete production [...] quality management [...] system, passed Shanghai Food and Drug Administration “Medical Equipment Manufacturing Management Standard [...]–Sterile Medical [...]Device Implementing Regulations” and ISO13485:2003 quality system assessment. divine-med.com |
厦门] 经过中国国家食品药品监督管理局( SF DA)一年多的监督和检查,中国科学家研制的戊型肝炎疫苗应该在今年底之前就能用了。 innovax.cn | XIAMEN] After more than a year of scrutiny and [...] inspection by China's State Food and Drug Administration (SFDA), a hepatitis [...]E vaccine developed [...]by Chinese scientists should be available by the end of the year. innovax.cn |
)--(美国商业资讯)--Celgene Corporation (NASDAQ: [...] CELG)的子公司Celgene International [...] Sàrl今天宣布,REVLIMID®(来那度胺)已获得完整的批复,该批复包含了中国国 家 食 品 药品监督 管 理 局 ( S F DA)颁发的进口药品许可证(IDL),用于与地塞米松联合治疗既往接受过至少一种药物的复发性或难治性多发性骨髓瘤患者。 businesswire.com | )--Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that REVLIMID® (lenalidomide) has been granted full [...] approval, which [...] includes an Import Drug License (IDL) by the China State Food and Drug Administration (SFDA) for use [...]in combination with dexamethasone [...]as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. businesswire.com |
药品食品用干燥剂的标准主要是由国 家 食 品 药品监督 管 理 局 制 定 的药品包装容器(材料)标准:《药用固体纸袋装干燥剂标准》YBB00122005。 wisepac.com.cn | Standard for desiccants of drug and food mainly refers to the standard for package container (material) of drug [...] compiled by State Food and Drug Administration: Standard for [...]solid paper bagged desiccant of drug, YBB00122005. wisepac.com |
为进一步加强中药材的质量控制,根据国 家 食 品 药品监督 管 理 局 的 部署和安排,经中国国家药典委组织有关单位和专家对黄曲霉毒素、重金属及有害元素、农药残留量等有害物质的控制方法、限度值以及重点品种进行试验研究,拟在2010年版《中国药典》的基础上,进一步增加中药的安全性指标控制项目,尤其是加强对中药材中重金属及有害元素、黄曲霉毒素、农药残留量的控制。 chemlinked.com | The Chinese Pharmacopoeia Commission is seeking public comments on the limit values of noxious substances such as aflatoxin, heavy metal, detrimental chemicals and pesticide residue in traditional medicines. chemlinked.com |
在遵守有关法规问题上提供帮助,包括良好生产规范要求(GMP),产品召回,应对美 国 食 品 药品监督 管 理 局 的 检 查及警告函以及对记录的保存和追溯之要求。 khlaw.com | Assisting on compliance issues, including good manufacturing practice requirements, product recalls, U.S. FDA inspection practices and warning letters, and record keeping and traceability requirements khlaw.com |
全球性的各种活动在在显现这种理念:在美国 , 食 品 与 药品 管 理 监督 管 理 局( F DA )发布了关于新的“可负担护理法案”以及联邦政府要求菜单上需加上关于营养提示的标签。 unileverfoodsolutions.hk | This can be seen through initiatives across [...] the globe:- In the USA the Food and Drug Administration (FDA) released [...]information on [...]the new Affordable Care Act, federal requirements for nutrition labelling on menus. unileverfoodsolutions.hk |
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