首页 > 资讯 > FDA发布2013财年仿制药制剂和原料药厂场地费收费标准

出自识林

2013-01-16 FDA

FDA发布2013财年仿制药制剂和原料药厂场地费收费标准

Notice of Generic Drug User Fee—Facility Fee Rates for Fiscal Year 2013

根据FDA仿制药用户收费公告（联邦公告），根据场地位置是否在美国国内，2013财年仿制药原料药和制剂设施场所费费率如下：

• 国内制剂厂 (Domestic FDF facility)： $175,389
• 国外制剂厂 (Foreign FDF facility)：$190,389
• 国内API厂 (Domestic API facility)： $26,458
• 国外API厂 (Foreign API facility)：$41,458

2013财年缴费时间定于2013年3月4日，2014-2017财年定于各年10月1日第一个工作日，或其他法规规定时间。

对同一家企业两个生产场地是否缴纳两份设施场所费（Facility Fees），FDA似乎没有给出明确规定。按照Self-Identification of Generic Drug Facilities, Sites, and Organizations指南，公司必须提交设施场所识别（FEI）编号，该编号由FDA给定的，用于监控和追踪所管理的公司。如果某公司有一些独立的建筑，其距离非常近，在每个建筑中所进行的活动都与相同的运营企业密切相关，且由同一当地管理机构进行管理，FDA可以在一次审计中完成对其审计的，则FDA会仅赋予一个FEI编号。

注：GDUFA定义的原料药和制剂企业与常规意义的不一致。
GDUFA defines an FDF as:

(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;
(B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or
(C) any combination of an active pharmaceutical ingredient (as defined in the statute) with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).

GDUFA defines an API as:

(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—
(i) to be used as a component of a drug; and
(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or
(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).

相关内容

• 联邦公告原文:Notice of Generic Drug User Fee—Facility Fee Rates for Fiscal Year 2013
• 设施场所费（Facility Fees）问答：Facility Fees