Maintaining this labeling information worldwide is a complex process. Conversion services fda structured product labeling. Structured product labeling implementation guide for fda. The center for biologics evaluation and research cber and the center for drug evaluation and research cder will begin indexing spl in the product labeling for human drug and biologic products spl became. Information on electronic submission may be found in. Structured product labeling starttofinish structured product labeling submissions that comply with industry standards structured product labels spls are a small component of full ectd submissions, but they can pose an equal amount of difficulty for your regulatory team if technical specifications and data requirements are not fully understood. Structured product labeling spl is a health level seven hl7 standard based on clinical document architecture and hl7 reference information model rim accredited by the american national standards institute ansi for the exchange of product information. Fda spl is a software that aids pharmaceutical companies and the repackaging relabeling industry to author spl files needed to register with us food and drug administration.
Spl is a standard that is used by drug companies, fda and public to exchange or. All marketed drugs and devices have associated product labeling information that must be provided according to regional requirements. Enterprise publishing software an introduction to structured product labeling understanding and preparing for the fda s new electronic labeling submission standard. We also service individual case safety reports icsr, electronic medical device. Hl7 structured product labeling specification, spl implementation guide, and the. It is used as the basis for regulatory guidance documents and applications for exchange of product labeling. Introduction to fda structured product labeling spl r4. Without at least a working knowledge of extensible markup language xml structure and fda expectations related to. Labeling revisited fda holds that labeling encompasses any written, printed or graphic material containing drug information disseminated by or on behalf of the manufacturer of that drug for use by healthcare professionals. The fda and ema are implementing a set of rules for the electronic submission of labeling content. Content of labeling must be identical to the enclosed labeling text for the prescribing information, with the addition of any labeling changes in pending changes.
Fda labeling requirements new regulations compliance. The fdas new guidance offering questions and answers on the structured product labeling spl standard for labeling provides general help but lacks specifics such as templates to better assist regulated firms working to implement the new standard, experts tell pir. The ema requires companies to submit product information documents in qrdcompliant format. Assessing the impact of hl7fda structured product label spl. Medical device labeling requirements, structured product. The pragmatic xforms spl product is restricted computer software under the provisions of far 52. Implementing a structured content management solutionfor.
The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content. Pragmatic structured product labeling editor spl xforms. The application allows easy document authoring by displaying spl structured data in a comprehensive tree view. Structured product labeling spl is a standard used by the fda community to.
Food and drug administration fda issued a guidance, providing regulatory submissions in electronic format drug establishment registration and drug listing on its expanded requirements for submissions in the structured product labeling spl format. Apply to data engineer, production supervisor, operations analyst and more. Product characteristics color, shape, size, etc packaging. As of september 2004, the fda is planning for spl to become mandatory around july 2005. This draft guidance is intended to assist sponsors who submit the content of their product labeling to the center for drug evaluation and research cder and center for biologics evaluation and research cber using the structured product labeling standard spl in extensible markup language xml. Our eu labeling platform is the result of the customization and optimization of i4is alice technology offering a suite of modules that deliver boundless possibilities for all of your content. Dec 17, 2019 structured product labeling spl is a health level seven international hl7 standard which defines the content of human prescription drug labeling in an xml format. Information on electronic submission may be found in guidance.
The hl7 version 3 structured product labeling spl specification is a document markup standard that specifies the structure and semantics of the content of authorized published information that accompanies any medicine licensed by a medicines licensing authority. Understanding and preparing for the fdas new electronic. Structured product labeling spl data conversion laboratory. Take full advantage of i4is structured content authoring and management solution to achieve european regulatory compliance. Structured product labeling resources the structured product labeling spl is a document markup standard approved by health level seven hl7 and adopted by fda as a mechanism for exchanging product and facility information. Member earlybird rate register by october 7 and member. This includes the electronic labeling guidance 7 requiring that drug labels be submitted electronically, the physicians labeling rule.
This structured product labeling spl webinar will provide valuable assistance and a road map to device companies who need to learn how to properly create product and patient labeling information and meet minimum compliance expectations. Product labeling is a highly regulated and complex process. Reed tech has a long track record of helping drug product labelers meet spl submission requirements, beginning with fdas initial spl mandate in 2005. The veterans administrationkaiser permanente problem list snomed ct. The fda amendments act of 2007 public law 11085 requires that drug establishment. Muted enthusiasm greets fdas electronic labeling guidance. Marketing information category, status, start and end dates representative samples of cartoncontainer.
Structured product labeling electronic registrations and drug listings in june 2009, the u. Content of labeling as soon as possible, but no later than 14 days from the date of this letter, submit, via the fda automated drug registration and listing system elist, the content of labeling 21 cfr 601. The product label can include multiple documents targeted at diverse audiences such as patients, physicians and pharmacists. For industry fda regulatory consulting services fda. Structured product labeling submissions synchrogenix. The structured product labeling spl is a document markup standard approved by health level seven hl7 and adopted by fda as a mechanism for exchanging product and facility information. Fda spl is a software that aids pharmaceutical companies and the repackaging relabeling industry to author spl files needed to register with us food and drug administration the application allows easy document authoring by displaying spl structured data in a comprehensive tree view. Lead, ncpdp spl rems requirements task group fda pubic meeting, white oak, md july 2526, 20. Structured pharmaceutical product labeling sciformix.
Rems standardization via structured product labeling spl. Conversion services fda structured product labeling spl. Providing regulatory submissions in electronic format. Whether you are new to structured product labeling or an old hand, this session will help you avoid some common pitfalls that can slow your process, compliance, and time to market. The structured product labeling spl is a document markup standard approved by health level seven hl7 and adopted by fda as a mechanism for. Department of health and human services food and drug. Structured product labeling spl webinar on how medical device companies can create product and patient labeling information with minimum compliance requirements. Rockville, md, june 5, 2009the us food and drug administration issued a new guidance this week on indexing structured product labeling spl. This includes the electronic labeling guidance 7 requiring that drug labels be submitted electronically, the physicians labeling rule plr 8 that mandates more userfriendly labels. National library of medicine nlm produces the metathesaurus fda structured product labels mthspl, which is based on the food and drug administration fda structured product labeling spl.
This includes product labels, labeler code requests, establishment registration, lot distribution reporting ldr, risk evaluation and mitigation strategy rems, generic drug facility identification gdfi and physician labeling rule plr. Labeling contains a summary of the essential scientific information needed for the safe and effective use of the drug. Food and drug administration fda issued a guidance, providing regulatory submissions in electronic format drug establishment registration and drug listing on its expanded requirements for submissions in the structured product labeling. Structured product labeling spl is a health level seven international hl7 standard which. Feb 02, 2017 during my tenure at the fda i had the opportunity to work on the recently published draft guidance providing regulatory submissions in electronic format submission of manufacturing establishment information published december 28, 2016. As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling 21 cfr 314. Our team is working hard to be prepared to help your organization when health canadas guidance and compliance timeline is released. Style sheets from multiple sources enable the same content to be repurposed for different audiences. Standard structure and encoding of prescribing information.
The drug labeling includes all published material accompanying a drug, such as the prescribing information which contains a great deal of detailed information about the drug. The structured product labeling spl is a document markup standard developed by health level seven hl7 adopted by fda as their mechanism for submitting and sharing product information. The national council for prescription drug programs ncpdp work. Fda spl for spl r4 structured product labeling user manual. As of release 4 of the spl standard, 22,000 fda informational product inserts. Structured product labeling spl is a document markup standard approved by health level seven hl7 and adopted by fda as a mechanism for exchanging product and facility information. During my tenure at the fda i had the opportunity to work on the recently published draft guidance providing regulatory submissions in electronic format submission of manufacturing establishment information published december 28, 2016. Structured product labeling spl is a health level seven international hl7 standard which defines the content of human prescription drug labeling in an xml format. Developed by health level 7 hl7 under direction of fda. Food and drug administration fda issued a guidance. Spl is an hl7 standard that defines the content and structure of. This guidance explains that fdas center for drug evaluation and research cder and center for biologics evaluation and research. Fda finalizes new guidance to support medical device. Scope of structured product labeling the scope of the spl specification is the standardization of the markup of the content of product labeling, establishment registration, ndc labeler code request etc.
Globalsubmit software and regulatory services for ectd. The fda may distribute the product to the public through a redistributable file delivered by pragmatic data to the fda for this purpose. All other trademarks are the property of their respective companies and. After that date, all such filings must be made electronically through the fdas electronic submission gateway and encoded in xml, according to the rules set out in the hl7 structured product labeling spl standard and the fda implementation guide. Nov 06, 2010 structured product labeling spl an overview 1. Specializing in fda regulatory compliance software, services, and submissions for structured product labeling spl. A handful of new guidance documents released by the fda on tuesday aim to pave the way for medical device innovation by allowing developers to make iterative changes to the device and software. Structured product labeling, release 4 description. In january 2006, the united states food and drug administration us fda introduced structured product labeling spl format for submitting product and facility information and changes to label submissions. A product label is very specific and precise in its content, especially with respect to safety data and adverse effects. Jul 12, 2017 our team is working hard to be prepared to help your organization when health canadas guidance and compliance timeline is released.
Conversion services for structured product labeling spl. Contact fda follow fda on facebook follow fda on twitter view fda videos on youtube subscribe to fda rss feeds fda homepage contact number 1888info fda 18884636332. Fda guidance manufacturing establishment information idmp. Enterprise publishing software an introduction to structured product labeling understanding and preparing for the fdas new electronic labeling submission standard. Providing regulatory submissions in electronic format content of. Any other rights regarding the use, duplication, or disclosure of this computer software, according to far 52. The openfda drug product labeling api returns data from these submissions for both prescription and overthecounter otc drugs. Product labeling is a highly regulated and complex process that can include multiple documents targeted at diverse audiences such as patients, physicians and pharmacists.
Structured product labeling implementation guide for fda drug. The fda amendments act of 2007 public law 11085 requires that drug establishment registration and drug. Shakul hameed structured product labeling spl an overview 2. After that date, all such filings must be made electronically through the fda s electronic submission gateway and encoded in xml, according to the rules set out in the hl7 structured product labeling spl standard and the fda implementation guide.
The fda requires companies to submit xml labeling content in structured product labeling spl format. Medical devices are not currently included but are likely to be included in the future. Structured product labeling wikimili, the free encyclopedia. Fdas draft guidance on indexing structured product labeling spl the data model for indexing spl and making clinical information computer processable controlled terminologies used for indexing structured product labeling spl. The fda has embarked on an initiative to improve drug knowledge appropriate for use in clinical information systems. Assessing the impact of hl7fda structured product label. The structured product labeling spl is a document markup standard.
The intent of the draft guidance is to help industry with the most pressing problems related to. Guidance for industry indexing structured product labeling final. Implementing a structured content management solution for product labeling in a global pharmaceutical company business challenges. Structured product labeling how is structured product.
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