TRANSMITTING ELECTRONIC SUBMISSIONS USING eCTD SPECIFICATIONSTechnial - PDF document

TRANSMITTING ELECTRONIC SUBMISSIONS USING eCTD SPECIFICATIONSTechnial Specficas Documentisisorportollnt:Guidance for Industry Providing Regulatory Submissions inElectronic Format Certain HumanPharmaceutical Product Applicationsand Related Submissions Using theeCTD SpecificationsFor questios regaring his tchnicspecins docuent, contat CDER at esubda.hhs.govor CBER at esubprepda.hhs.gov U.S. Department ofalth and Human ServiFood and rug AdministraionCenter forDrug Evalation and Research (DER) Center forBiologics valuation nd Research (CBER) Trans m itting Ele c tronic S ubmissions U si n g eCTD Speci f ications 2 �� &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;�.96;&#x 37.;☣&#x 63.;℉&#x 49.;鈕&#x ]/S;&#xubty;&#xpe /;oot;r /;&#xType;&#x /Pa;&#xgina;&#xtion;&#x 000;&#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;�.96;&#x 37.;☣&#x 63.;℉&#x 49.;鈕&#x ]/S;&#xubty;&#xpe /;oot;r /;&#xType;&#x /Pa;&#xgina;&#xtion;&#x 000; &#x/MCI; 2 ;&#x/MCI; 2 ; &#x/MCI; 3 ;&#x/MCI; 3 ; &#x/MCI; 4 ;&#x/MCI; 4 ; &#x/MCI; 5 ;&#x/MCI; 5 ; &#x/MCI; 6 ;&#x/MCI; 6 ; &#x/MCI; 7 ;&#x/MCI; 7 ;Revision History Date Version Sum m ary of Changes 2005 - 05 - 25 1.0 Original version 2005 - 06 - 14 1.1 Correction of typographical error in Type of Media table 2009 - 08 - 27 1.2 R e m oval of Media Type Floppy Disk Updated LTO specificationsAdded inforation regarding ESG 2010 - 08 - 02 1.3 Change to Address for e l ectronic sub m ission sent on physical CDER Office of GenericDrugs address change 2011 - 12 - 28 1.4 Added infor m ation regarding USB media for m at Added retireent date for Tape optionsAdded ail address for Questons/Communication with Centers 2012 - 07 - 26 1.5 Clarification that USB encryption is optional Rewording infoation regarding pssword protection of data vs. USB drive 201 6 - 03 - 0 4 1.6 Addition of coversheet Change of document title Update to include ESG requirements and deadlinesChange to ddress for eectronic subission sent on physical Removal of ape optionsUpdate to CD ROM, DVD, and USB drive specificationsUpdate to edia preparation instructions 2017 - 06 - 22 1.7 Update to electronic submission date requirements, following update to the eCTD Guidance Update to CD ROM, DVD, and USB drive specifications 2019 - 0 4 - 01 1.8 Update to Physical Electronic Media addresses for submission from NPN7 to Central Document Room Trans m itting Ele c tronic S ubmissions U si n g eCTD Speci f ications 3 �� &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.96;&#x 37.;☣&#x 69.;℉&#x 49.;鈕&#x ]/S;&#xubty;&#xpe /;oot;r /;&#xType;&#x /Pa;&#xgina;&#xtion;&#x 000;&#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.96;&#x 37.;☣&#x 69.;℉&#x 49.;鈕&#x ]/S;&#xubty;&#xpe /;oot;r /;&#xType;&#x /Pa;&#xgina;&#xtion;&#x 000; &#x/MCI; 2 ;&#x/MCI; 2 ; &#x/MCI; 3 ;&#x/MCI; 3 ; &#x/MCI; 4 ;&#x/MCI; 4 ;TransmittingElectronicSubmissionssingeCTD SpecificationsThis document provides specificor transmitting electrnic subissions using eCTD specificatios. Details are inclued for traitting electronically via the FDA Electronic Submission Gateway (ESG) and onphyical ediaElectronic submissions that do not comply with thspecificationcannot be processed for review and are subject to rejection.CTRNIC RANSMISSIONFDA recommends the use of the Electronic SubmissionsGateway (ESG)See http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm for more information. NOTE:Beginning May 5, 2017, the ESG must be used for eCTD submissionsizes ofGB or lessfor NDABLAand Beginning May 5, 2018, the ESG must be used for eCTD submissionsizes ofGB or less for commercial INDsand master filesPlease see http://www.fda.gov/ectd for additional eCTD requirements PHYSICAL ELECTRONIC MEDIAPhysical electronic media should not be used for submissions that are 10GB or less in size.A. Addressfor submissionCBER:U.S. Food nd Drug AdnistrationCenter for Biologics Evaluation and ResearchDocuent Control Center10903 New Hampshire AvenueWO71, G112Silver Spring, MD Trans m itting Ele c tronic S ubmissions U si n g eCTD Speci f ications 4 �� &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [3;.96;&#x 37.;☣&#x 36.;℉&#x 49.;鈕&#x ]/S;&#xubty;&#xpe /;oot;r /;&#xType;&#x /Pa;&#xgina;&#xtion;&#x 000;&#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [3;.96;&#x 37.;☣&#x 36.;℉&#x 49.;鈕&#x ]/S;&#xubty;&#xpe /;oot;r /;&#xType;&#x /Pa;&#xgina;&#xtion;&#x 000; &#x/MCI; 2 ;&#x/MCI; 2 ; &#x/MCI; 3 ;&#x/MCI; 3 ;CDER:U.S. Food nd Drug Adinistration Center for Drugvaluation and Research Central Docuent RoomB Amendale Rd. Beltsville, MDB. Types of physical electronic media acceptedSee the ollwing tabl Media Type Format Submission Size CD ROM CD - R Over 10 GB to 45 GB DVD DVD - R DVD+R DVD+/ - R USB drive Device Type: External hard drive, including “thumb” drive Size not to exceed:Width: 4 inDepth: 5 inHeight: 1 inInterface: HiSpeed USB 3.0 (preferred) or 2.0 with Type A plugOptional passcode: use 6 to 24 digits Driverless operation Over 10 GB ontact the Agency Center by email in advance for specific instructions on how to send. For CDER, contact ESUB@fda.hhs.gov . For CBER, contact ESUBPREP@fda.hhs.gov . Trans m itting Ele c tronic S ubmissions U si n g eCTD Speci f ications 5 C. Media preparationSend all physical electronic edia inn adequtelysecuredprotective case or sleeve to avoid damage during transportThe following inforation should be included on the edia labels: Sponsor, applicant or company ne of the product, cheical or ingredientAppropriateregulatoryer (e.g., NDA aplication number) ission date (ddyyyy)Media series (e.g., “1 of 1”, “1 of 2”)To obtain instructions for sending USB driveto ask eneral uestions, please contact usCDER: ESUB@da.hh.gov CBER: ESUBPREP@fda.hhs.gov