Presentation on theme: "U.S. Food and Drug Administration"— Presentation transcript:
1 U.S. Food and Drug Administration Notice: Archived DocumentThe content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
2 Structured Product Labeling (SPL) CDR Vada Perkins, USPHSRegulatory Program Management OfficerFDA/CBER/OD
3 BACKGROUND Federal Register of December 11, 2003 (68 FR 69009) FDA published final regulations requiring that the content of labeling be submitted electronically “in a form" that FDA can process, review, and archive.CDER announced in public docket number 92S-0251 the following new procedures for electronic submission of content of labeling, effective October 31, 2005:PDF is no longer a format FDA can use to accept the content of labeling submitted electronically.Applicants should use the SPL standard when submitting all labels, labeling supplements, and amendments to FDA in XML.21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Establishment of Public Docket; Notice
4 CBER Notification http://www.fda.gov/oc/datacouncil/spl.html Subject: Docket 92S-0251 – TransmittalEffective Date: October 15, 2008Notification established Health Level Seven (HL7) Structured Product Labeling (SPL) in XML as the only acceptable presentation in electronic format for the submission of the content of labelingApplicable to the content of labeling with original submissions, supplements, and annual reports.Regulatory citation: (l), (d), (b), (b).
5 Structured Product Labeling (SPL) Electronic labeling standard developed by Health Level 7 (HL7)Utilizes eXtensible Markup Language (XML)Machine readable tags to improve search functionality across systemsUsability across multiple database platformsPromote electronic health information initiativesEnhance search capabilities
6 Current State Limited in: Readability Accessibility Usability paper labels and forms cannot be accessed by computer systems
8 Drug Registration and Listing (Paper) Forms (2656, 2657, 2658)
9 XML Structured Content <time value=" "/> <assignedEntity> <id extension=“VP00019" root=" "/> <representedOrganization> <name>Greatest Pharmaceuticals</name> <addr>Metropolis, MA, USA</addr> </representedOrganization> </assignedEntity></author> •SPL is created using Extensible Markup Language (XML) –similar to HTML for webpages•XML–Relatively human-legible –Machine readable–Tags (elements) permit search of key information•XML Documents –created via Notepad, Word Pad, XML editing tools, SPL authoring tools, SPL conversion services, Xforms, etc…•XSL Stylesheet –transforms the XML data to be viewed via web browser or printed documents
10 SPL Stylesheet View/Source Code Courtesy of Lonnie Smith, FDA
11 Benefits of SPL Improved access Computer Readable Information Systems Locate a specific section of the labeling and specific elements within labeling and product listing sections.Information SystemsXML easily imported into information systems for other uses (e.g., data mining).Publicly availableContent of Labeling is made available by the FDA thru NLM (DailyMed) to consumers and health care providers.
12 Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (7/11/08)Voluntary Pilot ProgramNDC Labeler Code RequestEstablishment RegistrationDrug Listing/Content of LabelingGuidance covers:How to submit the information electronically in Structured Product Labeling (SPL) files, using a defined terminology.Transition from paper-based to electronic submissions of drug establishment registration and drug listing information.What registration and listing information (including labeling) to submit.Test the performance of FDA’s electronic system for this type of submission.Mandatory (1 June 09)
13 FDA eLISTInboundTRANSMIT(NLM Web)(Redacted Listing Files)DailyMed websiteFDA ESGGatewayeListIndustryREPOSITORY.PassVALIDATEPROCESSFDA Web(Redacted Listing Files)websiteFailOutboundDATA FILES(Database Reports)RegistrationListingERROR MESSAGENDC Directory &Establishments WebsitesVALIDATION ERRORSValidation of Structured Product Labeling Data Elements
14 Data Source – SPL Documents NDC LCRListing/CoLLabeler Code:XXXXXLabeler DUNS #:Labeler Code:XXXXXLabeler DUNS #EstablishmentDUNS #(s)Type ofOperationsEstablishment RegistrationEstablishmentDUNS #(s)Type ofOperation(s)US AgentImporter(s)Courtesy of Lonnie Smith, FDA
15 SPL Terminology Only controlled terminology permitted in SPL. Terminology lists located on FDA Data Standards Council’s SPL web page:
16 SPL TerminologyOnly controlled terminology is permitted in SPL documentsTerminology lists are on FDA Data Standards Council’s SPL web page:Route of administrationDosage formPackage typeUnits of measure and units of presentationColorShapeCoatingSizeScoringImprint codesSymbolsSPL DEA ScheduleSection headingsCode system object identifiers (OIDs)Document Type including Content of Labeling TypeTime Units: Unified Code for Units of Measure (UCUM)Substances/Unique Ingredient Identifiers (UNIIs)Business OperationMarketing CategoryMarketing StatusEquivalence Codes