Generic Drug User Fee Amendments of 2012

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以后请记住这个缩写：GDUFA

Generic Drug User Fee Amendments of 2012

GDUFA, a historic first: Providing user fees for FDA to ensure timely review of applications for generic drugs

The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.

GDUFA is designed to build on the success of the Prescription Drug User Fee Act (PDUFA).  Over the past 20 years, PDUFA has ensured a more predictable, consistent, and streamlined premarket program for industry and helped speed access to new, safe and effective prescription drugs for patients.  GDUFA will also enhance global supply chain safety by requiring that generic drug facilities and sites around the world self-identify.

What are the fiscal year (FY) 2013 FDF and API facility fees for U.S. and foreign manufacturers?
The FY 2013 facility fees are:

Domestic FDF facility:  $175,389
Foreign FDF facility: $190,389
Domestic API facility:  $26,458
Foreign API facility:  $41,458

How much is the DMF fee?

The DMF fee for fiscal year (FY) 2013 (October 1, 2012 to September 30, 2013) is $21,340.  Additional information, including the methodology for calculating the fee, is available in Generic Drug User Fee – Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) Fee Rates for Fiscal Year 2013.

Q1. How much are the ANDA and PAS fees?

The FY 2013 ANDA fee is $51,520; the PAS fee is $25,760.  Additional information, including the methodology for calculating the fee, is available in Generic Drug User Fee – Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) Fee Rates for Fiscal Year 2013.

静夜思雨

2012年仿制药用户收费修正案
GDUFA，历史性的第一次：提供用户费FDA仿制药，以确保及时审查申请
仿制药用户收费修正案2012（GDUFA）旨在加速使用安全和有效的仿制药向公众和行业降低成本。该法要求支付使用费的行业补充审查仿制药申请和检查设施的成本。更多的资源，使原子能机构能够减少目前积压的未决申请，削减安全审查仿制药申请所需的平均时间，并增加基于风险的检验。
GDUFA设计处方药用户收费法（PDUFA）的基础上的成功。在过去的20年里，PDUFA确保更可预测，一致和精简的产业上市前程序和帮助的访问速度，安全和有效的新患者处方药。 GDUFA也将加强全球供应链的安全性要求，仿制药在世界各地的设施，场所自我认同。


什么是本财政年度（FY）2013年美国和外国厂商的FDF和API设施费？
2013财年的融资费用是：
国内FDF设施：175389美元
外国FDF设施：190389美元
国内原料药工厂：26458美元
外国API设施：41458美元


DMF费是多少？
DMF费财年（FY）2013（2012年10月1日至2013年9月30日）是21340美元。额外的信息，包括费用的计算方法，是在仿制药用户收费 - 简化新药申请（ANDA），前批准补充（PAS），与药物主文件（DMF）2013财年的费费率。


Q1。 ANDA和PAS费是多少？
2013财年安达费是51520美元;，，PAS费25760美元。额外的信息，包括费用的计算方法，是在仿制药用户收费 - 简化新药申请（ANDA），前批准补充（PAS），与药物主文件（DMF）2013财年的费费率。
百度的。

liuqygood2005

多谢分享。

1009889281

按照新的规定，FDA 按照每季度更新的ANDA checklist审核药企提交的文件，如果不符合，将被拒绝，再交51520美元。

现场检查通过后， 不管本年度是否检查，每年要交190389美元。

国人再申请美国市场，可要算算账。