FDA授予泛美卫生组织90万美元为其对信息中心所做的贡献

FDA awards $904,000 to Pan American Health Organization for information ‘hub’
6 P/ [2 U1 o; _* e; f8 ]2 U) mProject to provide data on medical products, regulatory processes

- R0 x. R2 X# C- m6 ZThe U.S. Food and Drug Administration today announced the award of a $904,000 cooperative agreement to the Pan American Health Organization (PAHO) to research and develop an information hub for medical products and related regulatory processes and systems in the Americas Region.
$ Z- [2 \$ b3 @+ P: ~8 L6 f
The award will help FDA, and all PAHO member states, to better understand other countries' regulatory systems, support capacity to use harmonized standards and guidelines across countries, and prevent, and if necessary respond more quickly to, problems in the medical product supply chain. The “hub” will collect and produce data and map structures and processes in the areas of medical products, including drugs, biologics, vaccines, medical devices and other medical products, and related regulatory processes and systems.

7 t! ^# T8 W3 E/ j! |& e) A, T“National regulatory agencies play a critical role in ensuring access to safe, effective, quality medical products for patients and consumers,” said FDA Commissioner Margaret A. Hamburg, M.D. “Improved data access and transfer will help the monitoring of medical products, ingredients, and components throughout the supply chain and help reduce the risk of importing unsafe products and/or their ingredients into the marketplace.”
# V: g6 o) C- Z$ y3 }
Established in 1902, PAHO works to improve the health and the quality of life of people of the Americas and serves as the Regional Office for the Americas of the World Health Organization. PAHO member states today include 38 countries in North, Central and South America, and the Caribbean.

Regulatory agencies in the Americas Region have different legal and regulatory frameworks, different institutional and administrative structures, different standards and guidelines, and different ways of collecting and analyzing information.

1 j% {. g: q: C6 {( n& ~Better collaboration among these agencies will build confidence and knowledge among the participants, stakeholders, and ultimately benefit patients and consumers throughout the region, according to Hamburg.

$ H& C  c' P! SThe cooperative agreement will be administered by the FDA’s Office of International Programs, in concert with the agency’s relevant product centers. OIP is the focal point of coordination for FDA’s global engagement.

http://www.fda.gov/NewsEvents/Ne ... ments/ucm228423.htm

美国食品与药品管理局因泛美卫生组织提供医疗用品和监控过程的信息中心规划奖给其904000美元
  ~- M7 r" S6 M' s& L3 |2 V# }
今天美国食品与药品管理局宣布对从事研究和发展一个美洲地区医学产品、相关的调节过程和系统的咨讯中心的泛美卫生组织(PAHO)给予904000美元合作协议奖金。

% ]7 L* W$ O- d) x" R7 C这个奖金将帮助美国食品与药品管理局和所有的泛美卫生组织成员国更好地理解其它国家的监管系统，支持跨国使用协调标准和规则的能力，并且当需要快速反应时，预防在医学产品供应链中的问题。

) U3 J* s# V# a$ c8 c这个“中心”将收集和提供医疗用品领域的数据、地图结构和过程，包括药物、生物制剂、疫苗、医疗设备、其它医疗用品和相关的监管过程和系统。
+ N2 ^- Q  w" H+ h) R0 F8 z
6 z) r/ M9 _+ R& M0 p' x) [* v% W1 \“国家监管机构在确保患者和消费者获得安全、有效、优质的医疗用品中发挥关键的作用，”美国食品与药品管理局委员Margaret A. Hamburg医学博士说。

“完善数据存取和转录将帮助整个供应链中医疗用品、材料和成分的监控，并且降低进口不安全产品和/或它们的成分进入市场的风险。”

& s. e) N. X9 ]2 }建立于1902年的泛美卫生组织致力于改善美州人民的健康和生活质量，并且作为世界卫生组织美洲区域办事处。现在泛美卫生组织成员国包括北美、中美、南美和加勒比海地区的38个国家。

1 j1 g% ~' c: U- d/ l( _" @& U; i1 l美洲地区的监管机构有不同法定的和监管的框架，不同制度的和行政的结构，不同标准和规则，以及不同收集和分析信息的方式。

根据Hamburg所说，这些机构间更好的合作将在参加者之间建立信任和理解，最终使整个地区的患者和消费者受益。
- A( `1 B* p. O. e/ [: b& w
& ^: ]5 }! Z; J/ H  \这个合作协议将由美国食品与药品管理局国际项目办公室和该机构相关产品中心一起执行。国际项目办公室是美国食品与药品管理局全球视野的协调焦点。
6 K4 ~, A* E8 O3 p# i