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单词 国家食品药品监督管理局
释义

See also:

食品药品监督局

state food and drug administration (SDA)

External sources (not reviewed)

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 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
所有医疗设备必须 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
厦门] 经过中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
赛诺龙医疗公司首席执行官Louis P. Scafuri表示:“中 国家食品药品监督管理局 近 日 批准了我们的五类产品,这是赛诺龙在华业务发展的一个重要的里程碑。
tipschina.gov.cn
Louis P. Scafuri, Chief Executive Officer of Syneron
[...]
Medical, said, "The recent SFDA approval
[...] of these five products is a significant milestone for Syneron's business in China.
tipschina.gov.cn
于2005 年2月通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
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 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
Koning目前正在申请美国食品药品管 局 ( F D A) 认证、中 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
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 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
)--(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
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 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
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 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
药品食品用干燥剂的标准主要是 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 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
(c) 国家臭氧机构、海关事务署 国家食品药 物 管理监督局 、 环 境住房城市发展 部及其他化学品管制部门之间合作和数据交流的组织和进展。
multilateralfund.org
(c) Organisation of and progress in cooperation and data exchange between the NOU, the
[...] Customs Service, National Agency for Food and Drug Administration and Control and [...]
the Ministry of Environment,
[...]
Housing and Urban Development, as well as other chemical regulatory agencies.
multilateralfund.org
国批准的通用型药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
在 2011 年 3 月 22 日的第二次会议上,印度财 政部税务司特别秘书、西班牙国家药物管制计划政府代表、乌拉圭毒品问题国 家秘书处秘书长、哈萨克斯坦打击 品 商 业和药物管制委员会主席、老挝人民 民主共和国理办公厅主任国家药 物 管 制 与 监督 委 员 会主席、阿富汗内政部 负责禁毒事务的副部长、沙特阿拉伯禁毒 局局 长 和 法国打击毒品和吸毒问题 部门间特派团主席作了开幕发言。
daccess-ods.un.org
At the 2nd meeting, on 22 March 2011, opening statements were made by the Special Secretary of the Department of Revenue of the Ministry of Finance of India, the Government Delegate for the National Drug Control Plan of Spain, the Secretary-General of
[...]
the National
[...] Secretariat on Drugs of Uruguay, the Chairman of the Narcotic Business Combating and Drug Control Committee of Kazakhstan, the Minister to the Prime Minister’s Office and Chairman of the National Commission for Drug Control and Supervision of the Lao People’s Democratic Republic, the Deputy Minister of the Interior for Counter-Narcotics of Afghanistan, the Director General of the General Directorate of Narcotics [...]
Control of Saudi Arabia
[...]
and the President of the Interdepartmental Mission for the Fight against Drugs and Drug Addiction of France.
daccess-ods.un.org
中央一级还包含社区医疗和疾病控制中心、性别 和家庭保护事务部、吸毒预防和康复事务部、马尔代 食品 和 药 物 管理局 及 国家 社会保护局。
daccess-ods.un.org
The central level also encompasses the Centre for Community Health and Disease Control (CCHDC), Department of Gender and Family Protection
[...]
Services (DGFPS), Department of Drug Prevention and Rehabilitation Services
[...] (DDPRS), Maldives Food and Drug Authority (MFDA) and National Social Protection Agency (NSPA).
daccess-ods.un.org
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 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
他表示,政府特别是环境保护部和 48 国家食品药物监督管理局都积 极地与各企业沟通以淘汰氟氯化碳,他并表示希望能够找到 办法解决当前拖延计量吸入器行业氟氯化碳淘汰项目得到批准的困难。
multilateralfund.org
He said the Government, particularly the
[...]
Ministry of Environmental
[...] Protection and the State Food and Drugs Administration, had engaged actively [...]
with enterprises to
[...]
phase out CFCs, and expressed the hope that a solution could be found to the difficulties currently delaying approval of the project for CFC phase-out in the MDI sector.
multilateralfund.org
该公司的第一个产品是Sensei 机器人导管系统,于2007年5月经 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
该产品的有效性和安全性得到保证, 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
发言的还有:多民族玻利维亚国总统埃沃·莫拉莱斯·艾 玛;洪都拉斯副总统维克托·乌戈·巴尼卡;阿富汗禁毒部长;巴西司法部长;伊 朗伊斯兰共和国内政部长兼药物管制总部秘书长;老挝人民民主共和国 理办 公厅主任国家药物管制与监督委员 会主席;俄罗斯联邦药物管 局局 长 ; 美 利坚合众国国家药物管制政策办公室主任;西班牙卫生、社会服务和平等部主 管社会服务和平等事务的国务秘书。
daccess-ods.un.org
Statements were also made by Evo Morales Ayma, President of the Plurinational State of Bolivia; Victor Hugo Barnica, Vice-President of Honduras; the Minister of Counter-Narcotics of Afghanistan; the Minister of Justice of Brazil; the Minister of the Interior and Secretary-General of the Drug Control Headquarters of the Islamic Republic
[...]
of Iran; the Minister
[...] to the Prime Minister’s Office and Chairman of the Lao National Commission for Drug Control and Supervision of the Lao People’s Democratic Republic; the Director of the Federal Drug Control Service of the Russian Federation; the Director of the Office [...]
of National Drug Control
[...]
Policy of the United States; and the Secretary of State for Social Services and Equality of the Ministry of Health, Social Services and Equality of Spain.
daccess-ods.un.org
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 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
美国海军是为国食品与药品管理局 批 准 函评估这个流感检测方法的重要合作伙伴,位于加利福尼亚州圣地亚哥的海军健康研究中心(NHRC)对存档和预期的临床标本进行检测,以确保测试的特异性,此外,海军第三医学研究所(NAMRU-3)还为开发和检测提供十分宝贵的禽流感病毒株分离。
tipschina.gov.cn
The U.S. Navy was an integral partner in evaluating this flu test for FDA clearance, [...]
with the Naval Health Research Center
[...]
(NHRC) in San Diego, CA providing testing on both archival and prospective clinical specimens to ensure the specificity of the test, while Navy Medical Research Unit-3 (NAMRU-3) provided invaluable access to avian influenza isolates for development and testing.
tipschina.gov.cn
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 国食 品药品监督管理局 ( FD A)和美国 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
为协助 各国对付针对粮食生产的恐怖主义而开展的活动包括:(a) 进行关于食品安全、 动植物健康问题的能力建设(培训班、各种项目),包括促进风险分析和加强基层 能力,以确国家能够监测、 诊断、报告和应对病虫害和疾病的爆发; ( b) 食品 标准法典委员会国际植 物保护公约制定有关标准;(c) 设立一个食物管理框 架以便对跨界动植物病虫害和疾病造成的食物链危机、粮食安全威胁和紧急情 况,以及对核放射性威胁级紧急情况,进行预防、预警、防备和应对工作;组织 国际论坛讨论与粮食和农业相关的生物风险管理问题。
daccess-ods.un.org
Specific activities that assisted countries in relation to terrorism targeted at food products included: (a) capacity-building (training courses, projects) concerning food safety, animal and plant health, including promotion of risk analyses and
[...]
developing base-level
[...] capacity to ensure national ability to monitor, diagnose, report and respond to pest and disease outbreaks; (b) the standard setting work of the Codex Alimentarius Commission and the International Plant Protection Convention; (c) the establishment of a Food Chain Crisis Management Framework for prevention, [...]
early warning,
[...]
preparedness and response to food chain crises caused by transboundary animal and plant pests and diseases, food safety threats and emergencies, as well as nuclear and radiological threats and emergencies; and the organization of international forums to discuss biological risk management in relation to food and agriculture.
daccess-ods.un.org
政府成立了原料用途监督专家小组; 国家 质 量 监督 检 验 检疫 局 交 流 检疫和装运前 消毒处理熏蒸授权数据;开展核查审计;为负责检疫和装运前消毒处理熏蒸许可证的机构 提供能力建设,用于(a) 与负责熏蒸许可证的机构开展联合调查(b) 制定新的检疫和装运前 消毒处理用途监督管理规定 ,以及(c) 建立用于甲基溴检疫和装运前消毒处理用途的新 的管理信息系统。
multilateralfund.org
It has: established an expert team for the supervision of feedstock use; exchanged data with the General Administration of Quality Supervision, Inspection and Quarantine on QPS fumigation authorization; conducted verification audits; and provided capacity building for the 13 agency responsible for QPS fumigation permits for (a) a joint survey with those responsible for fumigation permits (b) the formulation of new QPS use supervision and management regulations, and (c) the establishment of a new management information [...]
system for MB QPS uses.
multilateralfund.org
俄罗斯联邦 2005 年在空间研究及和平利用外层空间领域 国家 活 动是由俄 罗斯联邦航天局根据俄罗斯联邦空间计划、专门的全球轨道导航卫星系统方案和 其他专门计划与俄罗斯科学院国防 部 、民防、紧急情况和自然灾 管理 部 、信 息技术和通信部、联邦大地测量和地图绘制局、联邦水文气象和环 监督局 以及 空间信息和服务的其他客户和用户合作进行的。
oosa.unvienna.org
The national activities of the Russian Federation in the field of space research and the use of outer space for peaceful purposes in 2005 were carried out by the Russian Federal Space Agency in accordance with the Russian Federal Space Programme, the special federal Global Navigation Satellite System (GLONASS) programme and other special
[...]
programmes in cooperation with the Russian
[...] Academy of Sciences, the Ministry of Defence, the Ministry for Civil Defence, Emergency Situations and Natural Disaster Management, the Ministry for Information Technologies and Communication, the Federal Geodesy and Cartography Agency, the Federal Hydrometeorology and Environmental Monitoring Service and other clients and users of space information and services.
oosa.unvienna.org
Hansen Medical(纳斯达克股票代码: HNSN)今天宣布国食品 药品监督管理局 ( FD A)已经批准其新一代Sensei(R) X机器人导管系统上市,进一步拓展了医疗机器人在电生理方面(EP)的应用范围,而且公司推出了Artisan Extend(TM)控制导管。
tipschina.gov.cn
(NASDAQ: HNSN) today
[...] announced it has received U.S. Food & Drug Administration (FDA) clearance for its next generation Sensei(R) X Robotic Catheter System and [...]
it introduced the Artisan Extend(TM) Control Catheter.
tipschina.gov.cn
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