13 October Structured Product Labeling: Four Strategies to Comply with FDA s SPL Mandate

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Phillip Watson
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Structured Product Labeling: Four Strategies to Comply with FDA s SPL Mandate Antoinette

2 Agenda Structured Product Labeling History Benefits/Challenges of SPL 10 Musts for SPL Success How to Connect with Reputable Vendors & Resources How to Factor the Future of SPL into Today s Information Management Decisions Questions & Discussion Copyright 2010 e-submissionssolutions.com 2

3 SPL History October 2005 New Drug Applications to FDA CDER Draft labeling with application Approved labeling following negotiation sndas, prior approval supplements Copyright 2010 e-submissionssolutions.com 3

4 SPL History October 2008 Biologic License Applications to FDA CBER Draft labeling with application Approved labeling following negotiation sbla or prior approval supplement Copyright 2010 e-submissionssolutions.com 4

5 SPL History June 2009 CBER, CDER, CVM FDA 2656 Drug Establishment FDA 2657 Drug Product Listing NDC Labeler Code SPL required To register establishments Submit listing information for all drugs in commercial distribution Annually by December 31 Previously unlisted drugs in June and December Copyright 2010 e-submissionssolutions.com 5

6 What is Structured Product Labeling? extensible Markup Language Standard structure and encoding of prescribing information Developed by Health Level 7 (HL7) under direction of FDA Developed with sponsor/vendor participation Style sheets from multiple sources enable the same content to be repurposed for different audiences Copyright 2010 e-submissionssolutions.com 6

10 Benefits of SPL Format Based on standards Code sets XML Style sheets Validation of compliance with the standards Repurposing of the content based on style sheets Enables FDA to efficiently perform regulatory due diligence Copyright 2010 e-submissionssolutions.com 10

11 Data Sharing Using SPL* NDC Directory CMS Physicians Industry FDA NLM Healthcare Info Suppliers Drug Firms Annual Registration Status Consumers *Lonnie Smith, FDA SPL Standards Coordinator

12 Challenges of SPL Format Traditional authoring tools don t automatically/easily translate into compliant SPL Failure to pass FDA validation process prevents review clock from starting Technical infrastructure requirements generally out of scope of traditional regulatory affairs staff Copyright 2010 e-submissionssolutions.com 12

13 SPL Prescribing Information Workflow FDA ESG or Media 1. Author Word processor or XML editor Inhouse or outsource 5. Submit 2. Convert ectd or waiver FDA or vendor 4. Publish 3. Validate Copyright 2010 e-submissionssolutions.com 13

16 SPL NDC Labeler Code, Drug Establishment, Drug Listing Workflow Low volume option No cost for software Requires FDA Electronic Submission Gateway (ESG) production account 4. Monitor ESG account 1. Create Xform 3. Transmit via ESG 2. Validate Copyright 2010 e-submissionssolutions.com 16

17 SPL NDC Labeler Code, Drug Establishment, Drug Listing Workflow High volume option Purchase dedicated system or outsource Requires FDA ESG production account 4. Monitor ESG account 1. Enter content Vendor system or spreadsheet 2. Validate Sponsor account Or thru vendor 3. Transmit via ESG Copyright 2010 e-submissionssolutions.com 17

18 Options for Meeting FDA s SPL Mandate Option Find a service provider Use a hosted application Implement a new XML tool Transform your in-house process Challenges XML experience alone is not enough; must have FDA SPL experience with history of high volume & rapid turnaround Free software = little to no support Labor-intensive & error-prone Insufficient for medium to high volume Few vendors with FDA SPL experience Finding a tool that meets all format needs MS Word, PDF, XML Usually combined with one of options listed above Copyright 2010 e-submissionssolutions.com 18

19 Timeline for SPL Strategy Determine SPL option Implement Option Test Option 3 to 6 months SOPs, Digital Certificates, Letter of Nonrepudiation, Sample submissions Initiate ESG Qualification Process Receive ESG Production Account Submit 1 to 3 months Copyright 2010 e-submissionssolutions.com 19

20 SPL Differences SPL Prescribing Information Word, XML, PDF, JPEG Submit in ectd or waiver Submit thru ESG or media At FDA reviewer s request during review cycle NDC Labeler Code, Drug Establishment, Drug Listing XML Submit via folder Submit thru ESG Calendared events Copyright 2010 e-submissionssolutions.com 20

21 10 Musts for Success 1. Develop in-house skills in XML 2. Partnership between RA and IT 3. Solution 3 months before deadline 4. Minimum of 2 ESG accounts 5. Monitor ESG accounts regularly 6. Be aware of FDA s internal SPL workflow 7. Take advantage of FDA s SPL education process 8. Continuous improvement process 9. ectd vs waiver 10. SPL PIM Copyright 2010 e-submissionssolutions.com 21

22 How to Connect with Reputable Vendors & Resources Assess your internal requirements & volume Current/projected product portfolio Locations of manufacturing Survey the vendor options In-house Outsource Request for Information/Proposal (RFI/RFP) Plan for process reengineering Copyright 2010 e-submissionssolutions.com 22

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