【讨论】2013年FDA法规进展

清歌一曲月如霜

The last year was a difficult year for theU.S. Food and Drug Administration. For quite a long time, Republicans andDemocrats couldn't agree on a spending plan for the fiscal year 2014, whichjust started on 1 October. On September 17, 2013, the Office of Management andBudget (OMB) sent out a memo advising federal agencies to begin preparing for agovernment shutdown. On 1 October, the United States federal government thenentered the government shutdown. After that, most FDA drug and device relatedfunctions only could have continued when funded through fees. But also beforethe official shutdown, the FDA had to suffer from budget restrictions. Despitethat, a lot of actions were ongoing. Here is a short summary of some selectedactivities:
Legislation
One of the most important legislations which passed the Congress and which was signed by the President was theDrug Quality and Security Act, with the main goal of giving the FDA new authorities in regulating compounding pharmacies.
For quite some time, the US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a consequence of the Heparin crisis. Already in 2008, the US FDA opened offices in China to increase the number of GMP Inspections. However, little progress has been made since that time. The US White House has published a statement on December 5th about a new agreement with China. According to a Pharmalot article, the US FDA will now increase its inspection activities.
Guidances
About 30 Guidances were drafted or issued. Three of them related to the above mentioned Drug Quality and Security Act. Some of the most relevant are listed here.
FDA was also proposing a new regulation to implement administrative detention authority during inspections.
Co-operation withEMA and the European Union
The European Medicine Agency (EMA) and the U.S. Food and Drug Agency (FDA) have published a joint question-and-ans***********ument that provides further guidance on the quality-by-design concept.
EMA and FDA published a joint report on the pilot program on Quality by Design (QbD) applications.
In a Press Release the US FDA announced that the U.S. is now a "listed" country" with the European Commission and does not need to issue Written Confirmations.
PharmaceuticalDevelopment and INDs
A new FDA document is supposed to provide a consistent approach to the handling of submissions of investigational new drug applications (INDs) within the Center for Drug Evaluation and Research (CDER). This concerns the processes within the FDA as well as the communication with the applicant.
FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011.
Two new Question and Answer Documents on Investigational Drugs have been published.
Medical Devices
The draft of a Question and Ans*******ument entitled "The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers" is new and provides proposals for the use of Good Laboratory Practice (GLP) under research and marketing authorisations for medical devices.
The UDI topic (Unique Device Identification) which is a code enabling the unique identification of medical devices has become of high importance for the FDA. In so far, the new provisions on UDI systems were published at the end of September in the Federal Register.
The FDA finalised a draft from July 2011 on the question: "Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff".
The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) in fiscal year 2013 (199 Warning Letters) has set a new record (181 were issued in 2012). Among the 199 Warning Letters issued in fiscal year 2013, "only" 159 refer to cGMP requirements for medical devices (Quality System Regulations (QSR) in 21 CFR 820).
Since July 2013, cGMP requirements on combination products apply in the USA as per 21 CFR Part 4.
Other importantactivities
The US FDA has published a comprehensive list of facilities that produce Finished Dosage Forms, APIs under the Generic Drug User Fee Act.
Since the introduction of the Generic Drug User Fee Act (GDUFA) all Drug Master File (DMF) holders are required to pay a fee and the DMFs have to undergo a completeness assessment. The FDA has published a list with all DMFswhich meet these criteria
FDA now offers eLearning for eCTD Implementation and has launched a new service on the website.

清歌一曲月如霜

过去的一年是艰难的一年theU.S.食品和药物管理局。在相当长的时间，共和党andDemocrats不能同意的支出计划在2014年财政年度， whichjust 10月1日开始。于2013年9月17日，管理andBudget办公室（ OMB ）发出一份备忘录建议联邦机构开始准备a政府关闭。 10月1日，美国联邦政府thenentered政府关闭。在此之后，大多数美国FDA药品和医疗设备relatedfunctions只能继续当通过收费资金。但也beforethe正式关闭，美国FDA已经从预算的限制之苦。 Despitethat ，很多行动正在进行之中。下面是一些selectedactivities的简短摘要：
立法
一个通过了国会和这是由总统签署的最重要的法例是theDrug质量和安全法案，以给FDA的新当局在调节复利药店的主要目标。
相当一段时间以来，美国FDA已经阐述了具体的计划，以增加检查的在中国的数量。这些计划被开发作为肝素危机的后果。在2008年已经，美国FDA开设了办事处在中国加大GMP检查的次数。然而，几乎已经取得了进展，因为那个时候。美国白宫发表了关于与中国的新协议， 12月5日的声明。据Pharmalot文章，美国FDA现在将增加其检查活动。
指导原则
约30时代启示起草或发行。他们三人与上述药品质量和安全法案。一些最相关的列在这里。
FDA还提出了新规定在检查中实施行政拘留的权威。
合作withEMA和欧盟
欧洲医学机构（EMA ）和美国食品和药物管理局（ FDA）曾发表联合问一答*********** UMENT ，提供进一步的指导上的质量由设计概念。
EMA和FDA公布的试点方案对质量源于设计（QbD ）的应用程序的联合报告。
在一份新闻稿中美国FDA宣布，美国现在是一个“上市”国“与欧盟委员会，并不需要发出书面确认函。
PharmaceuticalDevelopment及独立非执行董事
一个新的FDA的文件应该提供一个一致的方法来研究性新药申请（独立非执行董事）的中心内的药品评价和研究（ CDER）提交的处理。这涉及了FDA内的过程，以及在申请人的通信。
美国FDA公布的监测临床试验的指导方针。这份文件是一个日期为2011年8月草案的最终版本。
在研药物两个新的问题和答案文件已经印发。
医疗器械
一个问题的草案，并答******* UMENT题为“良好实验室规范在上市前提交的设备的适用范围：问与答”是新的，并提供建议，正在研究使用良好实验室规范（GLP）和上市许可的医疗器械。
UDI的主题（唯一设备识别），这是使医疗设备的唯一识别码，已成为非常重要的FDA认证。在目前为止，对UDI系统的新规定在联邦登记册刊登在九月底。
美国食品药物管理局敲定草案从2011年7月的问题： “移动医疗应用 - 行业指南和食品药品监督管理局的工作人员” 。
由中心器械和辐射健康中心（CDRH ）于2013财年（ 199警告信）发出警告信的数量已经创下新的纪录（ 181是在2012年颁布） 。其中在2013财年发行的199警告信， “只” 159是指对医疗器械cGMP的要求（ 21 CFR 820质量体系法规（ QSR ） ） 。
自2013年7月，申请在美国的组合产品cGMP要求按照21 CFR第4 。
其他importantactivities
美国FDA已经公布了生产成品剂型，原料药下的仿制药用户收费法设施的完整列表。
自推出仿制药用户收费法（ GDUFA ）的所有药物主文件（DMF ）持有人须支付一定的费用和DMF文件均经过完整的评估。 FDA已经发布的所有DMFswhich符合这些标准的清单
FDA现在提供电子教学的eCTD实施和推出了网站上的新服务。

一起看海

maokanmingbai shadongdong

syhorchid

顶一下

彩虹

了解下.....

wangjin1023

学习下啊啊

hldmfw

顶一下      

一沙一叶

这个是翻译工具直接翻译的吧

tsingsea

中英对照？

是是而非

支持一下

nunqing

一起看海 发表于 2014-1-19 13:50
maokanmingbai shadongdong

哈四八名吧

nunqing

一起看海 发表于 2014-1-19 13:50
maokanmingbai shadongdong

环艺一哈

nunqing

清歌一曲月如霜 发表于 2014-1-19 13:21
过去的一年是艰难的一年theU.S.食品和药物管理局。在相当长的时间，共和党andDemocrats不能同意的支出计划在 ...

都是共党，一家人啊

胜利者

顶起

一起看海

nunqing 发表于 2014-1-19 23:18
环艺一哈

啥玩意啊？？？