FDA GUDFA II問與答（一）

08-03

FDA GUDFA II問與答（一）

來自專欄藥品註冊管理

FDA GUDFA II問與答（一）

前言：GDUFA II從去年開始實施，其中出現許多問題，現就根據FDA網站上的問答進行翻譯，希望跟大家一起加深學習，將會分為3塊發布，首先介紹「Program Fees」，如有理解不當之處，還請指出- by April

Program Fees

1. What is the generic drug applicant program fee?什麼是仿製葯申請項目費用？

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包含仿製葯申請項目費用，即每年評估一次。每個公司及其附屬公司，依據ANDA獲批數量來評估年項目費用。項目費用分為三個級別，以此來決定需繳納數額。

Large: 20 or more approved ANDAs; 高：獲批數量大於等於20個

Medium: between 6 and 19 approved ANDAs; 中：獲批數量6~19個

Small: 5 or fewer approved ANDAs 低：獲批數量小於等於5個

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.

片語「附屬機構」定義為企業單位，即如果與第二個商業實體有關係（直接或間接），一個業務實體控制（或具有權控制）其他業務實體；或第三方控制（或有權控制）這兩個業務實體。

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前所有獲批的ANDA清單，包含母公司名稱和項目費用級別。請確認你的附屬機構，同時確認你和你附屬機構獲得的ANDA數量，以及確認2018.4.1前所提交的任何撤回申請。為了保證機構有充足的時間對所有權進行程序轉讓，FDA鼓勵申請人於2018.4.1前遞交該信息。

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

涉及附屬機構和獲批ANDA的信息可傳遞至 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).

撤回申請和所有權轉讓信息必須通過ESG通道傳遞至ANDA的正式檔案中。

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

以下文件最新更新日期為2018.5.21

Program Fee List - Excel file (987 KB)
Program Fee List - CSV file (12 KB)

2. When is the Program fee due?項目費用截止時間？

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.

項目費用將於本財政年度的10月1日到期。如果10月1日為周末，聯邦假日，或FDA關閉，則費用截止日期順延至工作日。某些ANDA於10月1日之後獲批，獲批的ANDA將在下個財年度被納入到母公司產品集內。

3. What is the penalty for not paying the program fee?沒有繳納項目費用將遭遇什麼懲罰措施？

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.

如果申請人沒有繳納項目費用將會受到以下三方面影響：（1）如果超過截止日期20天內沒有繳納費用，母公司將會被納入公共欠款名單。（2）申請人或其附屬機構所提交的ANDA將被拒收。（3）根據該申請人或附屬機構持有的任何簡略新葯申請銷售的所有藥物，均應被視為違標藥物。

4. Are discontinued ANDAs included in the calculation of Program fees?中止的ANDA是否納入項目費用評估中？

Yes, discontinued ANDAs are still considered approved ANDAs for user fee purposes unless these ANDAs are officially withdrawn.

是的，除非這些ANDA通過正式撤回途徑，否則中止的ANDA仍然被認定為獲批的ANDA，納入進用戶費用里。

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個ANDA，其附屬公司B擁有16個ANDA，他們需要繳納的是低等費用還是中等費用？或者，需要合併繳納高額費用？

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為附屬關係，他們則必須合併一起繳納高額費用。根據21 U.S.C. § 379j-42(b)(2)(E)要求，如果公司擁有附屬機構，則應合併為一個項目費用進行評估。

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

如果兩家公司為附屬關係，母公司是否需要支付項目費或由附屬機構繳納？

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

不論是母公司還是任何附屬公司均可代表母公司進行項目費用繳納。

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

變更已批准ANDA清單的最後期限是什麼時候？

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財年至2022財年，如果申請人於上一個財年的4月1日前遞交獲批ANDA的撤回申請，則該ANDA可被視為未獲得批准。

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個獲批的ANDA，如果該公司於2018.4.1當天或之前遞交一個ANDA的撤回申請，那麼，該公司在2019財年所要繳納的項目費用級別從中等變為低等級。

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.

對於所有權轉換，合併和公司產品集的其他變化，FDA將利用截至10月1日的有效信息來確定項目費用級別。

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個獲批的ANDA，同時請求將2個ANDA合併為1個，但是在2018年10月1日之後仿製葯辦公室未批准其合併請求，則2019財年的公司級別仍然為中級（仍然按照6個ANDA計算）。
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個ANDA，而這家公司被認定為另一家公司（有1個ANDA）的附屬機構，並且所屬日期在2018年10月1日之前，則2019財年的公司級別為中級。如果該公司仍然按照低級別進行支付，則他們需要支付二者的差額。

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

其他未列出的情況，請聯繫CDERCollections@fda.hhs.gov 以獲得幫助。

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

行業何時應向機構通報其附屬機構？

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，擁有ANDA的公司，或該公司指定的附屬機構，應該向機構遞交（代表公司和該公司的附屬機構）清單，內容包括：（1）該公司所有獲批的ANDA清單列表；以及（2）任何該公司的附屬機構所擁有的ANDA，所有擁有ANDA的附屬公司和此類公司所擁有的ANDA。

9. Are there any drugs or applications excluded from the Program fee? 是否有藥物或申請不需要繳納項目費用？

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.

以下申請不需要繳納項目費用：PET藥物，以及由州或聯邦政府提交的關於未進行商業銷售的藥物的申請。

10. How does a company pay the program fee?公司如何繳納項目費用？

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

通過用戶繳費系統創建項目費用清單，然後通過支票，電匯，或支付方式進行費用繳納。

11. What if the wrong tier is displayed on the coversheet?如果繳費清單上顯示錯誤的繳費級別怎麼辦？

Please contact CDERCollections@fda.hhs.gov. 請聯繫 CDERCollections@fda.hhs.gov。

原文來源於：國際藥品註冊網&廣州佳鑫醫藥科技有限公司

本譯文著作權歸作者所有，非經作者或國際藥品註冊網授權，不得轉載。