eCTD Important Notices

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="eCTD Important Notices" /> <meta name="dcterms.title" content="eCTD Important Notices" /> <meta name="dcterms.creator" content="Center for Drug Evaluation and Research" /> <meta name="dcterms.description" content="eCTD Important Notices" /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.type" content="Article" /> <meta name="dcterms.source" content="FDA" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/ectd-important-notices" /> <meta property="og:title" content="eCTD Important Notices" /> <meta property="og:updated_time" content="Wed, 09/18/2024 - 10:38" /> <meta property="article:publisher" content="FDA" /> <meta property="article:published_time" content="Wed, 09/18/2024 - 09:02" /> <meta property="article:modified_time" content="Wed, 09/18/2024 - 10:38" /> <meta name="google-site-verification" content="tWxlDhm4ANdksJZPj7TBmHgNoMqZCnecPp0Aa2vC9XA" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@US_FDA" /> <meta name="twitter:title" content="eCTD Important Notices" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@graph": [ { "@type": "Article", "headline": "eCTD Important Notices", "name": "eCTD Important Notices", "description": "eCTD Important Notices", "datePublished": "Wed, 09/18/2024 - 09:02", "dateModified": "Wed, 09/18/2024 - 10:38", "author": { "@type": "Organization", "name": "Center for Drug Evaluation and Research" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta property="og:description" content="eCTD Important Notices" /> <meta property="twitter:description" content="eCTD Important Notices" /> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/ectd-important-notices" /> <link rel="canonical" href="https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/ectd-important-notices" /> <link rel="shortlink" href="https://www.fda.gov/node/363226" /> <script src="/files/google_tag/production/google_tag.script.js?spd7fh" defer></script> <title>eCTD Important Notices | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_1reGTN8IJomDe9NNXuGLDghsOFcqPHURMZ3XKurXneU.css?delta=0&language=en&theme=preview&include=eJxlj1GOwjAMRC8UyP6sxG0i1zEhIslEsRdUTg8FUSr2xxqPpZlnPkvMhhFyi9JsKuCz32h3RDO6iqKK3-i9S0AqEqhRmS2z-m_D6awm1U-k4vqQS5arTwUTlZ3aXHJL_2weuZu6CTC1Qd13dFxkuGOkwG9WaSdqLPUBqZ6YMWJGC4a0AOgJwxhR3BKt_jn3FfGvyCsHtZe8JLxu4ffnsDEfL8MaTNSvagXlQbdZ0oc8Un92vfe1fbeC3QF5KozJ" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxlj1GOwjAMRC8UyP6sxG0i1zEhIslEsRdUTg8FUSr2xxqPpZlnPkvMhhFyi9JsKuCz32h3RDO6iqKK3-i9S0AqEqhRmS2z-m_D6awm1U-k4vqQS5arTwUTlZ3aXHJL_2weuZu6CTC1Qd13dFxkuGOkwG9WaSdqLPUBqZ6YMWJGC4a0AOgJwxhR3BKt_jn3FfGvyCsHtZe8JLxu4ffnsDEfL8MaTNSvagXlQbdZ0oc8Un92vfe1fbeC3QF5KozJ" /> <script src="https://script.crazyegg.com/pages/scripts/0024/3700.js" async></script> <script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=FDA&sdor=fda.gov&dclink=true" language="javascript" id="_fed_an_ua_tag"></script> <script>window.dataLayer = window.dataLayer || [];function gtag(){dataLayer.push(arguments)};gtag("js", new Date());gtag("set", "developer_id.dMDhkMT", true);gtag("config", "G-273DTKB5QW", {"groups":"default","page_placeholder":"PLACEHOLDER_page_location","allow_ad_personalization_signals":false});</script> </head> <body class="role-anonymous path-node page-node-type-article has-glyphicons"> <div id="quicklinks" class="sr-only"> <ul> <li><a href="#main-content" class="sr-only sr-only-focusable" tabindex="1">Skip to main content</a></li> <li><a href="#search-form" class="sr-only sr-only-focusable" tabindex="1">Skip to FDA Search</a></li> <li><a href="#section-nav" class="sr-only sr-only-focusable" tabindex="1">Skip to in this section menu</a></li> <li><a href="#footer-heading" class="sr-only sr-only-focusable" tabindex="1">Skip to footer links</a></li> </ul> </div> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M95XGZW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="main-container container-fluid"> <div class="row"> <header class="lcds-header container-fluid" role="heading" aria-level="1"> <div class="row us-masthead"> <div class="usa-banner col-xs-12"> <img class="usa-banner__us-flag" src="/themes/custom/preview/assets/images/US_Flag.png" alt="U.S. flag" /> <span>An official website of the United States government</span> <a id="USMenuButton" class="collapsed" data-toggle="collapse" data-target="#USABannerMenu" aria-controls="USABannerMenu">Here’s how you know <span class="toggle-indicator"> </span></a> <div class="col-xs-12 collapse usa-banner__menu" id="USABannerMenu" aria-labelledby="USMenuButton"> <div id="gov-banner" class="row usa-banner-content usa-grid usa-accordion-content" aria-hidden="true"> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-dot-gov.svg" alt="Dot gov" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The .gov means it’s official.</strong><br>Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.</p> </div> </div> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-https.svg" alt="SSL" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The site is secure.</strong><br> The <strong>https://</strong> ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.</p> </div> </div> </div> </div> </div> </div> <div class="alert alert-warning margin-left-neg-2 margin-right-neg-2 margin-top-3 margin-bottom-1"> <p>On Oct. 1, 2024, the FDA began implementing a <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More">reorganization</a> impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.</p> </div> <div class="row fda-masthead"> <div class="col-xs-4 col-md-8"> <a href="/" title="FDA Homepage"> <h1 class="fda-masthead__fda-logo">U.S. Food and Drug Administration</h1> </a> </div> <div class="col-xs-8 col-md-4"> <ul class='fda-masthead__item-list'> <li><a title="" id="btn-search" class="btn btn-default btn-sm fda-masthead__btn-search"> <span class="fa fa-search" aria-hidden="true"> </span> <span class="fda-masthead__btn-label">Search</span> </a></li> <li><a id="menu-btn" class="btn btn-default btn-sm fda-masthead__btn-menu collapsed" href="#primary-nav" data-toggle="collapse" aria-expanded="true"> <span class="fa fa-bars" aria-hidden="true"> </span> <span class='fda-masthead__btn-label'>Menu</span> </a></li> </ul> </div> <form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8" > <div class="search-popover" id="search-popover"> <div class="input-group pull-right" id="search-group"> <label class="sr-only" for="search-query">Search FDA</label> <input class="form-control search-input" id="search-query" name="s" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text" /> <span class="input-group-btn" id="input-group-btn"> <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button> </span> </div> </div> </form> </div> <nav id="primary-nav" class="lcds-primary-nav row collapse"> <div class="col-md-5 col-lg-4"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Featured</h2> <ul class="lcds-primary-nav__list lcds-primary-nav__list--featured"> <li class="lcds-primary-nav__list-item"><a href="https://www.safetyreporting.hhs.gov/smarthub#/" title="Report a Problem with an FDA Regulated Product">Report a Product Problem</a></li> <li class="lcds-primary-nav__list-item"><a href="/about-fda/contact-fda">Contact FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information/search-fda-guidance-documents">FDA Guidance Documents</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety/recalls-market-withdrawals-safety-alerts">Recalls, Market Withdrawals and Safety Alerts</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events/newsroom/press-announcements">Press Announcements</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">Warning Letters</a></li> <li class="lcds-primary-nav__list-item"><a href="/advisory-committees">Advisory Committees</a></li> <li class="lcds-primary-nav__list-item"><a href="/fda-en-espanol">En Espa&#241ol</a></li> </ul> </section> </div> <div class="col-md-7 col-lg-8"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Products</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/food">Food</a></li> <li class="lcds-primary-nav__list-item"><a href="/drugs">Drugs</a></li> <li class="lcds-primary-nav__list-item"><a href="/medical-devices">Medical Devices</a></li> <li class="lcds-primary-nav__list-item"><a href="/radiation-emitting-products">Radiation-Emitting Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/vaccines-blood-biologics">Vaccines, Blood, and Biologics</a></li> <li class="lcds-primary-nav__list-item"><a href="/animal-veterinary">Animal and Veterinary</a></li> <li class="lcds-primary-nav__list-item"><a href="/cosmetics">Cosmetics</a></li> <li class="lcds-primary-nav__list-item"><a href="/tobacco-products">Tobacco Products</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Topics</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/about-fda">About FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/combination-products">Combination Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information">Regulatory Information</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety">Safety</a></li> <li class="lcds-primary-nav__list-item"><a href="/emergency-preparedness-and-response">Emergency Preparedness</a></li> <li class="lcds-primary-nav__list-item"><a href="/international-programs">International Programs</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events">News and Events</a></li> <li class="lcds-primary-nav__list-item"><a href="/training-and-continuing-education">Training and Continuing Education</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations">Inspections and Compliance</a></li> <li class="lcds-primary-nav__list-item"><a href="/science-research">Science and Research</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Information For</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/consumers">Consumers</a></li> <li class="lcds-primary-nav__list-item"><a href="/patients">Patients</a></li> <li class="lcds-primary-nav__list-item"><a href="/industry">Industry</a></li> <li class="lcds-primary-nav__list-item"><a href="/health-professionals">Health Professionals</a></li> <li class="lcds-primary-nav__list-item"><a href="/federal-state-local-tribal-and-territorial-officials">Federal, State and Local Officials</a></li> </ul> </section> </div> </nav> </header> <div class="col-xs-12"> <div data-drupal-messages-fallback class="hidden"></div> </div> <section id="block-entityviewcontent" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <a class="lcds-button--expandable collapsed hidden-md hidden-lg" data-toggle="collapse" href="#section-nav" >In this section<span class="visible-sm-inline-block">: Electronic Regulatory Submission and Review </span> </a> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav hidden-md hidden-lg collapse"> <ul class="lcds-section-nav__list"> <li> <a href="/drugs/forms-submission-requirements/electronic-regulatory-submission-and-review" title="Electronic Regulatory Submission and Review" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link visible-xs-block visible-sm-block"> Electronic Regulatory Submission and Review </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_5 js-view-dom-id-050f2f9d4cf313e61fa10a90272e92c5293fbfc71adc5bb89433e404e7aad7ea"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd" class="lcds-section-nav__link">Electronic Common Technical Document (eCTD)</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/ectd-resources" class="lcds-section-nav__link">eCTD Resources</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/role-cder-health-level-seven-hl7-vulcan-accelerator" class="lcds-section-nav__link">Role of CDER in the Health Level Seven (HL7) Vulcan Accelerator</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/cder-data-standards-program" class="lcds-section-nav__link">CDER Data Standards Program</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/data-standards-drug-lifecycle" class="lcds-section-nav__link">Data Standards in the Drug Lifecycle</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/electronic-regulatory-submissions-and-review-helpful-links" class="lcds-section-nav__link">Electronic Regulatory Submissions and Review Helpful Links</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/electronic-submissions-presentations" class="lcds-section-nav__link">Electronic Submissions Presentations</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/study-data-submission-cder" class="lcds-section-nav__link">Study Data for Submission to CDER</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-2d5408e72ba86ac80a8bf252985b0039523dea2d1ac54ef2380a0891c59f0a9c"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/drugs/electronic-regulatory-submission-and-review/data-standards-manual-monographs" class="lcds-section-nav__section-link lcds-section-nav__link">Data Standards Manual (monographs)</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/drugs">Drugs</a> </li> <li > <a href="/drugs/development-approval-process-drugs">Development & Approval Process | Drugs</a> </li> <li > <a href="/drugs/development-approval-process-drugs/forms-submission-requirements">Forms & Submission Requirements</a> </li> <li > <a href="/drugs/forms-submission-requirements/electronic-regulatory-submission-and-review">Electronic Regulatory Submission and Review</a> </li> <li > <a class="current-link">eCTD Important Notices</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/drugs/forms-submission-requirements/electronic-regulatory-submission-and-review" title="Electronic Regulatory Submission and Review"> Electronic Regulatory Submission and Review </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">eCTD Important Notices</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fdrugs%2Felectronic-regulatory-submission-and-review%2Fectd-important-notices" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=eCTD%20Important%20Notices&url=https://www.fda.gov%2Fdrugs%2Felectronic-regulatory-submission-and-review%2Fectd-important-notices" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fdrugs%2Felectronic-regulatory-submission-and-review%2Fectd-important-notices&title=eCTD%20Important%20Notices&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=eCTD%20Important%20Notices&body=https://www.fda.gov%2Fdrugs%2Felectronic-regulatory-submission-and-review%2Fectd-important-notices" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p><strong>Notice 9/16/2024</strong><br> FDA FR announces support of eCTD v4.0 (<a href="https://www.federalregister.gov/documents/2024/09/16/2024-20897/electronic-common-technical-document-data-standards-center-for-drug-evaluation-and-research-and">Federal Register :: Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0</a>)</p> <p><strong>Notice 8/30/2021</strong><br> <a href="https://www.govinfo.gov/content/pkg/FR-2021-08-30/pdf/2021-18587.pdf">FDA FR Notice on high severity eCTD validations 1551&1553</a></p> <p><strong>Notice 8/25/2021</strong><br> <a href="https://www.govinfo.gov/content/pkg/FR-2021-08-25/pdf/2021-18303.pdf">FDA FR Notice on high severity eCTD validations 1306&1323</a>  </p> <p><strong>Notice 6/23/2021</strong><br> <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ec4b02d9-4527-4092-9c7c-f8fea92fbc60" href="/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd-v40" title="Electronic Common Technical Document (eCTD) v4.0">FDA eCTD v4.0 Validation and CTOC Posted</a>  </p> <p><strong>Notice 3/09/2021</strong><br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="23d1624d-7f5f-4c20-b6c6-608c5097c9f6" href="/media/100743/download?attachment" title="Technical Rejection Criteria for Study Data">FDA announces effective date for study data information  </a></p> <p><strong>Notice 1/18/2021</strong><br> <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ec4b02d9-4527-4092-9c7c-f8fea92fbc60" href="/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd-v40" title="Electronic Common Technical Document (eCTD) v4.0">FDA eCTD v4.0 Updates</a>  </p> <p><strong>Notice 11/9/2020</strong><br> <a href="https://www.regulations.gov/document?D=FDA-2018-D-1216-0017">FDA announces end of support for US Regional DTD v2.01 on March 1, 2022</a>  </p> <p><strong>Notice 7/27/2020</strong><br> <a href="https://www.accessdata.fda.gov/static/eCTD/submission-type.xml">eCTD Submission Type of REMS Supplement is now available</a>  </p> <p><strong>Notice 3/23/2020</strong><br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="37176bf6-4e96-4d21-bd46-906ddc41674a" href="/media/136412/download?attachment" title="NDA to BLA eCTD Transition Instruction to Industry">NDA to BLA Transition Instruction to Industry</a></p> <p>On March 23, 2020, the Biologics Price Competition and Innovation Act of 2009 required that an approved application for a “biological product” be deemed to be a license for the biological product. We are providing the additional instructions below to facilitate the initial eCTD submissions to such deemed BLAs on or after March 23, 2020.</p> <p><strong>Notice 6/21/2019</strong><br> <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4a2ed8a5-9c68-467a-b464-8c0a8ef910ed" href="/drugs/electronic-regulatory-submission-and-review/ectd-resources" title="eCTD Resources">Promotional Labeling and Advertising Materials Guidance</a>  </p> <p><strong>Notice 1/30/2019<br> FDA Extends Compliance Date for Submitting DMF Type lll in eCTD format</strong></p> <p>The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2020. See the FDA <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="10870ed3-14ef-4507-90af-80b47f364ee7" href="/media/85000/download?attachment" title="Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications">guidance document</a> for additional information on the compliance date and <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="72f2c8c2-e05d-4f80-b040-6cfdf811c45c" href="/drugs/forms-submission-requirements/drug-master-files-dmfs" title="Drug Master Files (DMFs)">FDA’s Drug Master File</a> page for additional information on DMFs. </p> <p><strong>Notice 11/30/2018</strong></p> <p>FDA plans to accept eCTD sequences with an eCTD submission type of “REMS Supplement” in the future. Implementation date is TBD. See submission-type.xml and M1 Specifications (located in the eCTD Submission Standards) for details. </p> <p><strong>Notice 6/1/2018<br> Please be advised that the FDA’s eCTD Access Data Website will update ciphers and SSL protocols in Production on September 1, 2018</strong>  </p> <p>Please make sure your system used to connect with the FDA’s eCTD Access Data website can connect with compatible secure ciphers and SSL protocols listed below.<br> SSL Protocols / Cipher Suites<br> TLS 1.1 or higher</p> <p>Example links to eCTD Access Data Website:<br> <a href="http://www.accessdata.fda.gov/static/eCTD/us-regional-v3-3.dtd">http://www.accessdata.fda.gov/static/eCTD/us-regional-v3-3.dtd</a><br> <a href="http://www.accessdata.fda.gov/static/eCTD/us-regional.xsl">http://www.accessdata.fda.gov/static/eCTD/us-regional.xsl</a></p> <p><strong>What action do you need to take?</strong><br> If you want to continue to access the eCTD Access Data website, you need to ensure your browser(s)/Servers have TLS 1.1 or higher enabled. If your browser or Servers do not have TLS 1.1 or higher enabled after FDA makes this change, then you will NOT be able to access these eCTD websites.  </p> <p>Backend servers that communicate with the eCTD Access Data Website links should also be communicating using TLS 1.1 or higher. Please contact your IT System Administrators or Technology Support personnel for appropriate methods to enable/upgrade your servers. </p> <p><strong>Notice 4/24/2018</strong><br> FDA Extends Compliance Date for Submitting DMF Type lll in eCTD format  </p> <p>The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2019. See the FDA <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="10870ed3-14ef-4507-90af-80b47f364ee7" href="/media/85000/download?attachment" title="Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications">guidance document</a> for additional information on the compliance date and <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="72f2c8c2-e05d-4f80-b040-6cfdf811c45c" href="/drugs/forms-submission-requirements/drug-master-files-dmfs" title="Drug Master Files (DMFs)">FDA’s Drug Master File</a> page for additional information on DMFs </p> <p><strong>Important Notice 5/18/2016<br> Third Acknowledgement for Successful eCTD Submissions</strong>  </p> <p>Beginning May 31, 2016, CDER will begin issuing an acknowledgement to FDA Electronic Submissions Gateway (ESG) users when their NDA, ANDA, BLA, IND, or DMF submission has successfully completed validation and processing and is available to the assigned review division. This acknowledgement is in addition to the ESG Message Delivery Notification acknowledgement (first acknowledgement) and the Official Center acknowledgement (second acknowledgement) and is referred to as the “third acknowledgement.” </p>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-09-18T10:38:00Z">09/18/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Drugs</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav"class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/drugs/forms-submission-requirements/electronic-regulatory-submission-and-review" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link"> Electronic Regulatory Submission and Review </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-0c89955839d19e7ba01f0e732125425bc7d782819d8847100d798483e923da50"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd" class="lcds-section-nav__link lcds-section-nav--side__link">Electronic Common Technical Document (eCTD)</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/ectd-resources" class="lcds-section-nav__link lcds-section-nav--side__link">eCTD Resources</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/role-cder-health-level-seven-hl7-vulcan-accelerator" class="lcds-section-nav__link lcds-section-nav--side__link">Role of CDER in the Health Level Seven (HL7) Vulcan Accelerator</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/cder-data-standards-program" class="lcds-section-nav__link lcds-section-nav--side__link">CDER Data Standards Program</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/data-standards-drug-lifecycle" class="lcds-section-nav__link lcds-section-nav--side__link">Data Standards in the Drug Lifecycle</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/electronic-regulatory-submissions-and-review-helpful-links" class="lcds-section-nav__link lcds-section-nav--side__link">Electronic Regulatory Submissions and Review Helpful Links</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/electronic-submissions-presentations" class="lcds-section-nav__link lcds-section-nav--side__link">Electronic Submissions Presentations</a></li> <li><a href="/drugs/electronic-regulatory-submission-and-review/study-data-submission-cder" class="lcds-section-nav__link lcds-section-nav--side__link">Study Data for Submission to CDER</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-22a284f65e86cc55352b21246f10292135adc1148d1e996201637dac8912ef33"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/drugs/electronic-regulatory-submission-and-review/data-standards-manual-monographs" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Data Standards Manual (monographs)</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </div> </section> </aside> </article> </main> </div> </div> <div class="region region-subscribe"> <section id="block-entityviewcontent-5" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> </section> </div> <footer class="lcds-footer container-fluid"> <div class="row lcds-footer__primary"> <h2 id="footer-heading" class="sr-only">Footer Links</h2> <nav class="text-center"> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/about-website/fdagov-archive" >FDA Archive</a></li> <li><a href="/about-fda" >About FDA</a></li> <li><a href="/about-fda/about-website/internet-accessibility" >Accessibility</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/visitor-information" >Visitor Information</a> </li> <li><a href="/about-fda/about-website/website-policies" >Website Policies / Privacy</a></li> <li><a href="/about-fda/jobs-and-training-fda/no-fear-act" >No FEAR Act</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" >Vulnerability Disclosure Policy</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/regulatory-information/freedom-information" title="Freedom of Information Act">FOIA</a></li> <li><a href="https://www.hhs.gov/" title="Health and Human Services" target="_blank">HHS.gov</a></li> <li><a href="https://www.usa.gov/" target="_blank">USA.gov</a></li> </ul> </div> </nav> </div> <div class="row lcds-footer__secondary"> <div class="col-sm-12 col-md-6 col-lg-4 lcds-footer__social-links"> <a href="/about-fda/contact-fda" class="btn btn-default btn-md">Contact FDA</a> <a href="https://www.facebook.com/FDA" title="Follow FDA on Facebook" class="no-disclaimer"> <span class="fa fa-facebook fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Facebook</span> </span> </a> <a href="https://x.com/US_FDA" title="Follow FDA on X" class="no-disclaimer"> <svg class="icon-svg-inline fa-2x" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> <span class="sr-only">Follow FDA on X</span> </a> <a href="https://instagram.com/FDA" title="Follow FDA on Instagram" class="no-disclaimer"> <span class="fa fa-instagram fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Instagram</span> </span> </a> <br class='visible-xs-inline'/> <a href="https://www.linkedin.com/company/fda/" title="Follow FDA on LinkedIn" class="no-disclaimer"> <span class="fa fa-linkedin fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on LinkedIn</span> </span> </a> <a href="https://youtube.com/@US_FDA" title="View FDA videos on YouTube" class="no-disclaimer"> <span class="fa fa-youtube fa-2x" aria-hidden="true"> <span class="sr-only">View FDA videos on YouTube</span> </span> </a> <a href="/about-fda/contact-fda/subscribe-podcasts-and-news-feeds" title="Subscribe to FDA RSS feeds"> <span class="fa fa-rss fa-2x" aria-hidden="true"> <span class="sr-only">Subscribe to FDA RSS feeds</span> </span> </a> </div> <a href="/" title="FDA Homepage"> <div class="visible-lg-block col-lg-4 text-center lcds-footer__logo"> <span class="sr-only">FDA Homepage</span> </div> </a> <div class="col-sm-12 col-md-6 col-lg-4 text-center lcds-footer__contact-number"> <span class="fa fa-phone" aria-hidden="true"> </span> <span class="sr-only">Contact Number</span> 1-888-INFO-FDA (1-888-463-6332) </div> </div>  </footer> <a href="" id="btn-top" class="btn btn-primary btn-top"><span class="sr-only">Back to </span>Top</a> </div> <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/363226","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"fda_ckeditor_enhancements":{"basePath":"modules\/custom\/fda_ckeditor_enhancements"},"google_analytics":{"account":"G-273DTKB5QW","trackOutbound":true,"trackMailto":true,"trackTel":true,"trackDownload":true,"trackDownloadExtensions":"7z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip"},"bootstrap":{"forms_has_error_value_toggle":1,"modal_animation":1,"modal_backdrop":"true","modal_focus_input":1,"modal_keyboard":1,"modal_select_text":1,"modal_show":1,"modal_size":"","popover_enabled":1,"popover_animation":1,"popover_auto_close":1,"popover_container":"body","popover_content":"","popover_delay":"0","popover_html":0,"popover_placement":"right","popover_selector":"","popover_title":"","popover_trigger":"click"},"ajax":[],"user":{"uid":0,"permissionsHash":"3aef67b4ac7d861d8624bf1f7ab2bc9cfc56d3c25b7d709dc15466dfa996dfb0"}}</script> <script src="/files/js/js_KwaVrVDnb9vBN4UOzg4J4320oQW-EMMozpPhvFZziRU.js?scope=footer&delta=0&language=en&theme=preview&include=eJxlj1GOwjAMRC8UyP6sxG0i1zEhIslEsRdUTg8FUSr2xxqPpZlnPkvMhhFyi9JsKuCz32h3RDO6iqKK3-i9S0AqEqhRmS2z-m_D6awm1U-k4vqQS5arTwUTlZ3aXHJL_2weuZu6CTC1Qd13dFxkuGOkwG9WaSdqLPUBqZ6YMWJGC4a0AOgJwxhR3BKt_jn3FfGvyCsHtZe8JLxu4ffnsDEfL8MaTNSvagXlQbdZ0oc8Un92vfe1fbeC3QF5KozJ"></script> <script type="text/javascript" src="/z4AWJAR8FMJAZ0Gr8yxw/N9Q3czz0N2Jrp9ma/HRNLRk0/JG/ooezF2J3gB"></script></body> </html>

CINXE.COM

eCTD Important Notices | FDA