Monthly Archives: 八月 2014

U.S. FDA eSubmitter 實務之一 – WebTrader test account 申請

U.S. FDA 從2009年6月1日起, 除特別許可外,不再接受紙本的工廠註冊(Drug Establishment Registration)及產品登記(Drug Listing)。

參考網頁: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114831.htm

1, 寄送紙本的Non-Repudiation Agreement Letter 到FDA, 同意FDA接受電子簽名的申請)。此信需用公司抬頭,手寫簽名,寄至

    Michael Fauntleroy
    Food and Drug Administration
    Center for Biologics Evaluation and Research
    11820 Parklawn Drive, Suite 300
    Rockville, MD 20852

文件範本及官方說明可以參考FDA網站: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm113964.htm

2, 發送 email 到 esgprep@fda.hhs.gov 申請WebTrader 測試帳號,並提供以下資料:

    Company name
    First and Last Name
    Phone Number
    Submission Method: (WebTrader)
    Indicate if you would like a WebTrader Hosted Solution (WTHS) account in addition to your WebTrader account. (For more information on WTHS accounts please click here26).

Continue reading »

1,719 total views, 2 views today