FDA's Global Substance Registration System

<!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="Information about FDA's Global Substance Registration System and the Unique Ingredient Identifier (UNII)" /> <meta name="dcterms.title" content="FDA's Global Substance Registration System" /> <meta name="dcterms.creator" content="Office of the Commissioner" /> <meta name="dcterms.description" content="Information about FDA's Global Substance Registration System and the Unique Ingredient Identifier (UNII)" /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.source" content="FDA" /> <meta name="dcterms.audience" content="Industry" /> <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/industry/fda-data-standards-advisory-board/fdas-global-substance-registration-system" /> <meta property="og:title" content="FDA's Global Substance Registration System" /> <meta property="og:description" content="Home of the Unique Ingredient Identifier (UNII)" /> <meta property="og:image" content="https://www.fda.gov/files/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg" /> <meta property="og:updated_time" content="Mon, 03/18/2024 - 03:34" /> <meta property="article:published_time" content="Mon, 03/25/2024 - 11:48" /> <meta property="article:modified_time" content="Mon, 03/18/2024 - 03:34" /> <meta name="google-site-verification" content="tWxlDhm4ANdksJZPj7TBmHgNoMqZCnecPp0Aa2vC9XA" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@US_FDA" /> <meta property="twitter:description" content="Home of the Unique Ingredient Identifier (UNII)" /> <meta name="twitter:title" content="FDA's Global Substance Registration System" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="twitter:image" content="https://www.fda.gov/files/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg" /> <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": "FDA\u0027s Global Substance Registration System", "name": "FDA\u0027s Global Substance Registration System", "description": "Information about FDA\u0027s Global Substance Registration System and the Unique Ingredient Identifier (UNII)", "image": { "@type": "ImageObject", "representativeOfPage": "True", "url": "https://www.fda.gov/files/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg" }, "datePublished": "Mon, 03/25/2024 - 11:48", "dateModified": "Mon, 03/18/2024 - 03:34", "author": { "@type": "Organization", "name": "Office of the Commissioner" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/industry/fda-data-standards-advisory-board/fdas-global-substance-registration-system" /> <link rel="canonical" href="https://www.fda.gov/industry/fda-data-standards-advisory-board/fdas-global-substance-registration-system" /> <link rel="shortlink" href="https://www.fda.gov/node/359799" /> <script src="/files/google_tag/production/google_tag.script.js?smjbjq" defer></script> <title>FDA's Global Substance Registration System | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_nIAEFYPN7y_O0y9dA__6_ZBSGy8omYOK6rvMeZ1warY.css?delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <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-sub-section 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">: FDA Data Standards Advisory Board </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="/industry/fda-data-standards-advisory-board/fdas-global-substance-registration-system" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link">FDA's Global Substance Registration System</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-fd9cda7e32ffaadaf3170a72fc1d47858f7e40bb3ecf231446cd318084d22105"> </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-635c4bce65141b80edde8feeb65d2197e90ada0fc13f24dd73b0ccabd4682d8d"> </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="/industry">For Industry</a> </li> <li > <a href="/industry/fda-data-standards-advisory-board">FDA Data Standards Advisory Board</a> </li> <li > <a class="current-link">FDA's Global Substance Registration System</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/industry/fda-data-standards-advisory-board" title="FDA Data Standards Advisory Board"> FDA Data Standards Advisory Board </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-14" 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">FDA's Global Substance Registration System</h1> <h2 class="article-subtitle text-center">Home of the Unique Ingredient Identifier (UNII)</h2> <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%2Findustry%2Ffda-data-standards-advisory-board%2Ffdas-global-substance-registration-system" 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=FDA%27s%20Global%20Substance%20Registration%20System&url=https://www.fda.gov%2Findustry%2Ffda-data-standards-advisory-board%2Ffdas-global-substance-registration-system" 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%2Findustry%2Ffda-data-standards-advisory-board%2Ffdas-global-substance-registration-system&title=FDA%27s%20Global%20Substance%20Registration%20System&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=FDA%27s%20Global%20Substance%20Registration%20System&body=https://www.fda.gov%2Findustry%2Ffda-data-standards-advisory-board%2Ffdas-global-substance-registration-system" 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"> <figure> <div> <div class="field field--name-image field--type-image field--label-inline"> <div class="field--label">Image</div> <div class="field--item"> <picture> <source srcset="/files/styles/main_image_small/public/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg?itok=gUNBBJBO 1x" media="all and (max-width: 320px)" type="image/jpeg" width="320" height="180"/> <source srcset="/files/styles/main_image_medium/public/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg?itok=jpBcXt8n 1x" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg?itok=jpBcXt8n 1x" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg?itok=jpBcXt8n 1x" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_1/public/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg?itok=zOv7zxX5 1x" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" width="1020" height="574"/> <source srcset="/files/styles/main_image_1/public/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg?itok=zOv7zxX5 1x" media="all and (min-width: 1201px)" type="image/jpeg" width="1020" height="574"/> <img loading="eager" src="/files/styles/main_image_medium/public/G-SRS-Graphic-FDA-Voices-02-1600x900.jpg?itok=jpBcXt8n" width="500" height="281" alt="Computer screen showing the G-SRS" class="img-responsive" /> </picture> </div> </div> </div> </figure> <h2>Improving Regulated Product Safety and Availability</h2> <p>Globalization has fueled an ever-rising number of imported FDA-regulated products and ingredients. It has also spurred the growing movement of clinical trials abroad.  As our world becomes more interdependent, FDA has been working closely with the National Institutes of Health (NIH) and international stakeholders to promote the knowledge-sharing required to tackle globalization’s impacts on our nation’s public health.</p> <p>Among these impacts has been an unmet need for a system that can accurately track the global supply chain of ingredients in FDA-regulated products.  Currently, consumers, clinicians, and researchers do not always have a way to tell what ingredients are contained in commercial products that are domestically and foreign-sourced.  This is due to the fact that certain ingredients are not included in the labeling and others are labeled ambiguously.  For example, food product labels often contain very general terms like “spices” or “artificial flavoring.”  There is clearly a need for an accurate substance repository.  This common system with common content will enable global monitoring of food, medicinal, tobacco, and cosmetic products and help the global community achieve this goal.</p> <p>To this end, <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="edfd02bf-cccc-4b15-bbe4-8cff3b5dc6ee" href="/about-fda/office-digital-transformation/office-health-informatics" title="Office of Health Informatics">FDA’s Informatics team</a>, <a href="https://tripod.nih.gov/ginas/#/about">NIH's National Center for Advancing Translational Sciences </a>(NCATS), and the <a href="https://www.ema.europa.eu/en">European Medicines Agency </a>(EMA) have collaborated to create a Global Substance Registration System (GSRS) that will enable the efficient and accurate exchange of information on what substances are in regulated products.</p> <p>Instead of relying on names--which vary across regulatory domains, countries, and regions—the GSRS knowledge base makes it possible for substances to be defined by standardized, scientific descriptions. It classifies substances as chemical, protein, nucleic acid, polymer, structurally diverse, or mixture as detailed in the ISO 11238  (<a href="https://www.iso.org/standard/69697.html">International Organization for Standardization</a>)  and <a href="https://www.iso.org/standard/70594.html">ISO DTS 19844</a>.</p> <p>FDA’s GSRS generates Unique Ingredient Identifiers (UNIIs) used in electronic listing as seen in <a href="https://dailymed.nlm.nih.gov/dailymed/">DailyMed</a>.  It is also used for other regulatory activities throughout product life cycles.  This would encompass <a href="https://clinicaltrials.gov/">clinical trial phases</a>,  product marketing and postmarket surveillance.</p> <p>Beginning in 2006, FDA created a Substance Registration System and unique ingredient identifiers because no other code system met the agency’s regulatory needs. UNIIs can be generated at any time in the regulatory life cycle for any substance, from an atom to an organism.</p> <p>Public UNII sources include: A flat file (spreadsheet) and simple search developed for electronic listing submitters hosted at <strong><a href="https://precision.fda.gov/uniisearch">precisionFDA</a></strong> and a public Global Substance Registration System hosted by the <a href="https://ginas.ncats.nih.gov/ginas/app">National Center for Advancing Translational Sciences</a>. Users of precisionFDA can filter and export GSRS public data and create GSRS JSON records in their own user space. They can also use a precisionFDA shared space to collaborate with the FDA-SRS team.</p> <p>For UNII requests, data issues, or questions about GSRS contact:<br> <a href="mailto:FDA-SRS@fda.hhs.gov">FDA-SRS@fda.hhs.gov</a><br>  </p> <h3>Quick Guide for Creating a Structure Data (SD) File</h3> <p>The <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4d5690eb-ffcf-43c7-b9e6-182ab5ed6b94" href="/media/161877/download?attachment" title="Quick Guide to Creating an SD File">Quick Guide to Creating a Structure-Data File (SD File) for Electronic Common Technical Document</a> (eCTD) Submissions assists industry in how to prepare SD Files for ANDAs, NDAs, and BLAs and provides additional resources.</p> <h3>How to Register Chemicals or Proteins in FDA's Global Substance Registration System within precisionFDA</h3> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f5bd9333-cc3e-4408-b42d-7ed04a34a944" href="/media/169513/download?attachment" title="How to register chemicals and proteins in FDA’s Global Substance Registration System within precisionFDA">Registering Chemicals or Proteins in FDA's GSRS Within precisionFDA</a></p> <h3>Don't Miss the FDA Grand Rounds Webcast on the GSRS</h3> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a23f798f-4ff1-455a-9ed1-25506634227e" href="/science-research/fda-grand-rounds/fdas-global-substance-registration-system-gsrs-unique-ingredient-identifiers-uniis-uniquely-define" title="FDA’s Global Substance Registration System (GSRS) Unique Ingredient Identifiers (UNIIs) uniquely define substances in FDA-regulated products - 06/08/2023">FDA’s Global Substance Registration System (GSRS) Unique Ingredient Identifiers (UNIIs) uniquely define substances in FDA-regulated products</a></p> <br> <br> </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="2024-03-18T03:34:00Z">03/18/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> </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="/industry/fda-data-standards-advisory-board/fdas-global-substance-registration-system" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link">FDA's Global Substance Registration System</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-313d56dc7388e9167e6df6ee5ceda7c0d526ea55baf7ef44ab70ad41ad63368f"> </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-5d08068e4da02c69833dac519c758d8e2713d14b021a1f6b07f07544d4ef9a36"> </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\/359799","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_jmx6639WuKcEs1DgFSmm8g__5ByGF4YtLnPWvZO-XrM.js?scope=footer&delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A"></script> <script type="text/javascript" src="/Glj4GCbp15rt1JYQ1bjdCY17/OOpiQpwDbfwtpO1S/LygGdz4/IiljWE0/wM2Y"></script></body> </html>

CINXE.COM

FDA's Global Substance Registration System | FDA