FDA GUDFA II问与答（一）

恨我不成钢

FDA GUDFA II问与答（一）

前言：GDUFA II从去年开始实施，其中出现许多问题，现就根据FDA网站上的问答进行翻译，希望跟大家一起加深学习，将会分为3块发布，首先介绍“Program Fees”，如有理解不当之处，还请指出

Program Fees

1. What is the generic drug applicant program fee?什么是仿制药申请项目费用？

GDUFA II includes a Generic Drug Applicant Program Fee, which is assessed annually. Each company and its affiliates will be assessed an annual program fee depending on the number of approved ANDAs in their portfolio. To determine the fee amount, there are three tiers of the program fee:

GDUFA II包含仿制药申请项目费用，即每年评估一次。每个公司及其附属公司，依据ANDA获批数量来评估年项目费用。项目费用分为三个级别，以此来决定需缴纳数额。

Large: 20 or more approved ANDAs;

高：获批数量大于等于20个

Medium:  between 6 and 19 approved ANDAs; 中：获批数量6~19个

Small: 5 or fewer approved ANDAs

低：获批数量小于等于5个

The term “affiliate” is defined as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third party controls, or has the power to control, both of the business entities.

词组“附属机构”定义为企业单位，即如果与第二个商业实体有关系（直接或间接），一个业务实体控制（或具有权控制）其他业务实体；或第三方控制（或有权控制）这两个业务实体。

Below is the list of all approved ANDAs as of January 31, 2018, along with parent company names and corresponding program fee tiers. Please confirm your affiliates and approved ANDAs owned by you and your affiliates, and submit any ANDA withdrawal requests by April 1, 2018.  To ensure the Agency has enough time to process Transfers of Ownership, FDA also encourages Applicants to submit this information by April 1, 2018.

以下是2018.1.31前所有获批的ANDA清单，包含母公司名称和项目费用级别。请确认你的附属机构，同时确认你和你附属机构获得的ANDA数量，以及确认2018.4.1前所提交的任何撤回申请。为了保证机构有充足的时间对所有权进行程序转让，FDA鼓励申请人于2018.4.1前递交该信息。

Information regarding affiliates and approved ANDAs can be sent to CDERCollections@fda.hhs.gov.

涉及附属机构和获批ANDA的信息可传递至 CDERCollections@fda.hhs.gov.

Withdrawal requests and Transfers of Ownership must be sent to the official record of the ANDA via the Electronic Submissions Gateway (ESG).

撤回申请和所有权转让信息必须通过ESG通道传递至ANDA的正式档案中。

The following files were last updated on 5/21/2018

以下文件最新更新日期为2018.5.21

Program Fee List - Excel file (987 KB)

Program Fee List - CSV file (12  KB)

2. When is the Program fee due?项目费用截止时间？

The program fee is due on October 1 of the fiscal year. If October 1 falls on a weekend, federal holiday, or day when the FDA is otherwise closed, then the fee is due on the following business day. Any ANDA approved after October 1 will be included in the parent company’s portfolio for the following fiscal year.

项目费用将于本财政年度的10月1日到期。如果10月1日为周末，联邦假日，或FDA关闭，则费用截止日期顺延至工作日。某些ANDA于10月1日之后获批，获批的ANDA将在下个财年度被纳入到母公司产品集内。

3. What is the penalty for not paying the program fee?没有缴纳项目费用将遭遇什么惩罚措施？

There are three effects if an applicant fails to pay the program fee: (1) If the program fee is not paid within 20 calendar days after the due date, the parent company will be placed on a publicly available arrears list. (2) Any ANDA submitted by the applicant or its affiliates will not be received. (3) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded.

如果申请人没有缴纳项目费用将会受到以下三方面影响：（1）如果超过截止日期20天内没有缴纳费用，母公司将会被纳入公共欠款名单。（2）申请人或其附属机构所提交的ANDA将被拒收。（3）根据该申请人或附属机构持有的任何简略新药申请销售的所有药物，均应被视为违标药物。

4. Are discontinued ANDAs included in the calculation of Program fees?中止的ANDA是否纳入项目费用评估中？

Yes, discontinued ANDAs are still considered approved ANDAs for user fee purposes unless these ANDAs are officially withdrawn.

是的，除非这些ANDA通过正式撤回途径，否则中止的ANDA仍然被认定为获批的ANDA，纳入进用户费用里。

5. If Company A that has 4 approved ANDAs is affiliated with Company B that has 16 approved ANDAs, can they pay a small and medium fee? Or, must they pay one large fee?如果公司A有4个ANDA，其附属公司B拥有16个ANDA，他们需要缴纳的是低等费用还是中等费用？或者，需要合并缴纳高额费用？

If Company A and B are affiliated, then they must pay one large fee. According to 21 U.S.C. § 379j-42(b)(2)(E), if a person has affiliates, a single program fee shall be assessed.

如果公司A和B为附属关系，他们则必须合并一起缴纳高额费用。根据21 U.S.C. § 379j-42(b)(2)(E)要求，如果公司拥有附属机构，则应合并为一个项目费用进行评估。

6. If two companies are affiliated, does the parent company have to pay the program fee or can the affiliate pay the fee?

如果两家公司为附属关系，母公司是否需要支付项目费或由附属机构缴纳？

Either the parent company or any of the affiliated companies can pay the program fee on behalf of the parent company.

不论是母公司还是任何附属公司均可代表母公司进行项目费用缴纳。

7. When is the deadline for making changes to the approved ANDA list?

变更已批准ANDA清单的最后期限是什么时候？

For FY 2019 through FY 2022, an ANDA shall be deemed not to be approved if the applicant has submitted a request for withdrawal of approval of such ANDA by April 1 of the previous fiscal year.

2019财年至2022财年，如果申请人于上一个财年的4月1日前递交获批ANDA的撤回申请，则该ANDA可被视为未获得批准。

For example, if a company has 6 approved ANDAs and a withdrawal request is submitted for one ANDA before or on April 1, 2018, then the company’s program fee tier would change from medium tier to small tier for FY 2019.

例如，如果一家公司有6个获批的ANDA，如果该公司于2018.4.1当天或之前递交一个ANDA的撤回申请，那么，该公司在2019财年所要缴纳的项目费用级别从中等变为低等级。

For transfers of ownership, consolidations, and other changes to a company’s portfolio, FDA will use the information effective as of October 1 to determine program fee tier.

对于所有权转换，合并和公司产品集的其他变化，FDA将利用截至10月1日的有效信息来确定项目费用级别。

For example, if a company has 6 approved ANDAs and requests a consolidation of 2 ANDAs into 1, but the Office of Generic Drugs does not grant the consolidation request until after October 1, 2018, then the company’s tier would remain medium tier for FY 2019 (total remains 6 ANDAs).

例如，如果一家公司有6个获批的ANDA，同时请求将2个ANDA合并为1个，但是在2018年10月1日之后仿制药办公室未批准其合并请求，则2019财年的公司级别仍然为中级（仍然按照6个ANDA计算）。

For example, if a company with 5 approved ANDAs is determined to be affiliated with another company with 1 approved ANDA, and the date of affiliation is prior to October 1, 2018, then the company’s tier would be medium tier for FY 2019. If the company had already paid the small tier, they would need to pay the difference between the medium tier fee and the small tier fee.

例如，如果一家公司有5个ANDA，而这家公司被认定为另一家公司（有1个ANDA）的附属机构，并且所属日期在2018年10月1日之前，则2019财年的公司级别为中级。如果该公司仍然按照低级别进行支付，则他们需要支付二者的差额。

For other scenarios not listed, please contact CDERCollections@fda.hhs.gov for assistance.

其他未列出的情况，请联系CDERCollections@fda.hhs.gov 以获得帮助。

8. When should the industry inform the Agency about their affiliates?

行业何时应向机构通报其附属机构？

By April 1 of each year, each person that owns an ANDA, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Agency a list of (1) all approved ANDAs owned by such person, and (2) if any affiliate of such person also owns an ANDA, all affiliates that own any such ANDA and all approved ANDAs owned by any such affiliate.
每年的4月1日，拥有ANDA的公司，或该公司指定的附属机构，应该向机构递交（代表公司和该公司的附属机构）清单，内容包括：（1）该公司所有获批的ANDA清单列表；以及（2）任何该公司的附属机构所拥有的ANDA，所有拥有ANDA的附属公司和此类公司所拥有的ANDA。

9. Are there any drugs or applications excluded from the Program fee? 是否有药物或申请不需要缴纳项目费用？

The following are excluded from the program fee: Positron emission tomography (PET) drugs, and applications submitted by a State or Federal Government entity for a drug that is not distributed commercially.

以下申请不需要缴纳项目费用：PET药物，以及由州或联邦政府提交的关于未进行商业销售的药物的申请。

10. How does a company pay the program fee?公司如何缴纳项目费用？

A company can create a program fee cover sheet via the User Fee System and then pay via check, wire transfer, or pay.gov.

通过用户缴费系统创建项目费用清单，然后通过支票，电汇，或支付方式进行费用缴纳。

11. What if the wrong tier is displayed on the coversheet?如果缴费清单上显示错误的缴费级别怎么办？

一沙一叶

过来学习一下

胜利者

认真学习

syhorchid

谢谢分享

blueangelhui

感谢楼主分享，刚好用到

小金库

楼主辛苦了，感谢分享