FDA Announces Initiative to Bolster Generic Drug Program
Effort will streamline generic drug approval process; provide more options for consumers, health professionals
The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.
The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.
“To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007.”
As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.
FDA now has about 215 full-time staff working on the review of generic drug applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from other FDA departments will be engaged in the effort. As well, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and Webcasts.
Generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug has the same dosage form, strength, route of administration, and conditions of use as the approved brand-name product. Generic drug manufacturers also must demonstrate bioequivalence, meaning they show that the drug delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.
看来SFDA与FDA还是差个“S”!
中国的企业不大有机会从中得益， 即便是普药，毕竟我们的制剂还没能真正地打入美国市场。
最后一条写着呢，要求还是很严格的，估计国内想卖到美国困难还是很大的。
从另外一个角度看,中国制剂公司费九牛二虎之力进入美国市场,到时候突然发现自己的竞争对手不仅仅是以前的品牌药公司和个别知名的通用名药厂了,在FDA的引导下,普药竞争越来越火暴,中国公司的产品的成本优势也许越来越小，生存的空间越来越小。
对中国打算进军FDA的药厂不知道是善事还是恶事，时间会证明一切。
看来SFDA与FDA还是差个“S”!
从另外一个角度看,中国制剂公司费九牛二虎之力进入美国市场,到时候突然发现自己的竞争对手不仅仅是以前的品牌药公司和个别知名的通用名药厂了,在FDA的引导下,普药竞争越来越火暴,中国公司的产品的成本优势也许越来越小，生存的空间越来越小。
对中国打算进军FDA的药厂不知道是善事还是恶事，时间会证明一切。
FDA的制度与审批模式皆值得我们学习。其制度的推出，是建立在其药品注册审批的发展基础上，也与其医疗保险支付的要求相适应的。
我们国家在此方面的工作刚刚开始。特别现行的医疗体制改革，争议很多。SFDA与国民医疗体制的关联性很难体现。
我们可以抱着学习的态度来观察这一切，可以扬弃嘛------
即使如您分析的那样,有打入总比没打入多一个选择.企业要做大的唯一选择.
机遇和风险并存！
FDA宣布启动促进仿制药审批的新行动计划
近日，美国食品药品监督管理局宣布（FDA）启动"仿制药价格及效益计划" (GIVE,Generic Initiative for Value and Efficiency)。该计划的目标是通过有效利用现有资源，完善FDA仿制药审批工作程序，使其更趋现代化和通畅,最终实现增加目前市场上仿制药的种类及数量。
FDA指出，经FDA审查并批准的仿制药品，仿制药与原创药具有相同的剂型、含量、给药途径及作用，其安全性及有效性能够得到充分的保证。FDA还明确指出，由于仿制药价格低于原创药的30—80%，所以加速仿制药的审批，消费者能够早日获得上市的仿制药品，就拥有更大的仿制药选择范围，也就意味着消费者将节省更多的医疗支出。
为实施GIVE计划，FDA规划了一系列具体工作内容。在GIVE计划中，FDA将采用调用FDA内部相关部门的人员，雇佣和培训仿制药新审评人员等方式整合仿制药审评审批的人力资源，强化申报资料及内部资料的电子化应用范围和程序，设置新审评程序，识别并简化仿制药低风险生产变更的审评投入，促进审评效率及审批数量的提升。
不管怎么样，总是一条出路。
看看国内和国外对待仿制药审批的态度，心里真是个寒啊。同一个产品，国内我05年报到SFDA的，现在八字还没一撇呢，而我们在印度总共从筹备到拿到批件开始生产，3个月时间，晕死了。
Effort will streamline generic drug approval process; provide more options for consumers, health professionals
The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.
The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.
“To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007.”
As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.
FDA now has about 215 full-time staff working on the review of generic drug applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from other FDA departments will be engaged in the effort. As well, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and Webcasts.
Generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug has the same dosage form, strength, route of administration, and conditions of use as the approved brand-name product. Generic drug manufacturers also must demonstrate bioequivalence, meaning they show that the drug delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.
看来SFDA与FDA还是差个“S”!
中国的企业不大有机会从中得益， 即便是普药，毕竟我们的制剂还没能真正地打入美国市场。
最后一条写着呢，要求还是很严格的，估计国内想卖到美国困难还是很大的。
从另外一个角度看,中国制剂公司费九牛二虎之力进入美国市场,到时候突然发现自己的竞争对手不仅仅是以前的品牌药公司和个别知名的通用名药厂了,在FDA的引导下,普药竞争越来越火暴,中国公司的产品的成本优势也许越来越小，生存的空间越来越小。
对中国打算进军FDA的药厂不知道是善事还是恶事，时间会证明一切。
看来SFDA与FDA还是差个“S”!
从另外一个角度看,中国制剂公司费九牛二虎之力进入美国市场,到时候突然发现自己的竞争对手不仅仅是以前的品牌药公司和个别知名的通用名药厂了,在FDA的引导下,普药竞争越来越火暴,中国公司的产品的成本优势也许越来越小，生存的空间越来越小。
对中国打算进军FDA的药厂不知道是善事还是恶事，时间会证明一切。
FDA的制度与审批模式皆值得我们学习。其制度的推出，是建立在其药品注册审批的发展基础上，也与其医疗保险支付的要求相适应的。
我们国家在此方面的工作刚刚开始。特别现行的医疗体制改革，争议很多。SFDA与国民医疗体制的关联性很难体现。
我们可以抱着学习的态度来观察这一切，可以扬弃嘛------
即使如您分析的那样,有打入总比没打入多一个选择.企业要做大的唯一选择.
机遇和风险并存！
FDA宣布启动促进仿制药审批的新行动计划
近日，美国食品药品监督管理局宣布（FDA）启动"仿制药价格及效益计划" (GIVE,Generic Initiative for Value and Efficiency)。该计划的目标是通过有效利用现有资源，完善FDA仿制药审批工作程序，使其更趋现代化和通畅,最终实现增加目前市场上仿制药的种类及数量。
FDA指出，经FDA审查并批准的仿制药品，仿制药与原创药具有相同的剂型、含量、给药途径及作用，其安全性及有效性能够得到充分的保证。FDA还明确指出，由于仿制药价格低于原创药的30—80%，所以加速仿制药的审批，消费者能够早日获得上市的仿制药品，就拥有更大的仿制药选择范围，也就意味着消费者将节省更多的医疗支出。
为实施GIVE计划，FDA规划了一系列具体工作内容。在GIVE计划中，FDA将采用调用FDA内部相关部门的人员，雇佣和培训仿制药新审评人员等方式整合仿制药审评审批的人力资源，强化申报资料及内部资料的电子化应用范围和程序，设置新审评程序，识别并简化仿制药低风险生产变更的审评投入，促进审评效率及审批数量的提升。
不管怎么样，总是一条出路。
看看国内和国外对待仿制药审批的态度，心里真是个寒啊。同一个产品，国内我05年报到SFDA的，现在八字还没一撇呢，而我们在印度总共从筹备到拿到批件开始生产，3个月时间，晕死了。