Structured Product Labeling: Four Strategies to Comply ...Oct 13, 2010 · What is Structured Product Labeling? z. eXtensible Markup Language . z. Standard structure and encoding

Copyright 2010 e-SubmissionsSolutions.com 1

Antoinette Azevedo, Presidente-SubmissionsSolutions.com

13 October 2010

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

Agenda

Structured Product Labeling HistoryBenefits/Challenges of SPL10 “Musts” for SPL SuccessHow to Connect with Reputable Vendors & ResourcesHow to Factor the Future of SPL into Today’s Information Management DecisionsQuestions & Discussion


SPL History

October 2005New Drug Applications to FDA CDER

Draft labeling with applicationApproved labeling following negotiation

sNDAs, prior approval supplements


SPL History

October 2008Biologic License Applications to FDA CBER

Draft labeling with applicationApproved labeling following negotiation

sBLA or prior approval supplement


SPL History

June 2009CBER, CDER, CVM

FDA 2656 Drug EstablishmentFDA 2657 Drug Product ListingNDC Labeler Code

SPL required To register establishmentsSubmit listing information for all drugs in commercial distribution

Annually by December 31Previously unlisted drugs in June and December


What is Structured Product Labeling?

eXtensible Markup Language Standard structure and encoding of prescribing informationDeveloped by Health Level 7 (HL7) under direction of FDADeveloped with sponsor/vendor participation

Style sheets from multiple sources enable the same content to be repurposed for different audiences


Traditional Prescribing Information


SPL Encoding in XML


SPL Via Style Sheet


Benefits of SPL Format

Based on standardsCode setsXMLStyle sheets

Validation of compliance with the standardsRepurposing of the content based on style sheetsEnables FDA to efficiently perform regulatory due diligence


Data Sharing Using SPL*

Industry FDA

NLM

HealthcareInfo

Suppliers

CMS

Drug Firms Annual

Registration Status

NDC Directory

Consumers

Physicians

*Lonnie Smith, FDA SPL Standards Coordinator

Challenges of SPL Format

Traditional authoring tools don’t automatically/easily translate into compliant SPLFailure to pass FDA validation process prevents review clock from startingTechnical infrastructure requirements generally out of scope of traditional regulatory affairs staff


SPL Prescribing Information Workflow

1. Author

2. Convert

3. Validate4. “Publish”

5. Submit


Word processoror XML editor

Inhouse or outsource

FDA or vendor

eCTD or waiver

FDA ESG or Media

SPL Location in eCTD


SPL Drug Establishment – Drug Listing Workflow


SPL NDC Labeler Code, Drug Establishment, Drug Listing Workflow

Low volume optionNo cost for softwarehttp://www.globalsubmit.com/XPortal/Requires FDA Electronic Submission Gateway (ESG) production account

1. Create Xform

2. Validate

3. Transmit via ESG

4. Monitor ESG account


http://www.globalsubmit.com/XPortal/

http://www.globalsubmit.com/XPortal/

SPL NDC Labeler Code, Drug Establishment, Drug Listing Workflow

High volume optionPurchase dedicated system or outsourceRequires FDA ESG production account

1. Enter content

2. Validate

3. Transmit via ESG

4. Monitor ESG account


Vendor system or spreadsheet

Sponsor accountOr thru vendor

Options for Meeting FDA’s SPL Mandate

Option Challenges

Find a service provider XML experience alone is not enough; must have FDA SPL experience with history of high volume & rapid turnaround

Use a hosted application “Free” software = little to no supportLabor-intensive & error-proneInsufficient for medium to high volume

Implement a new XML tool Few vendors with FDA SPL experienceFinding a tool that meets all format needs – MS Word, PDF, XML

Transform your in-house process Usually combined with one of options listed above


Timeline for SPL Strategy

Initiate ESG Qualification

Process

Receive ESG Production

AccountSubmit


Determine SPL

optionImplement

OptionTest

Option

3 to 6 months

1 to 3 months

SOPs, Digital Certificates,

Letter of Nonrepudiation,Sample submissions

SPL Differences

• Word, XML, PDF, JPEG• Submit in eCTD or waiver• Submit thru ESG or media• At FDA reviewer’s request

during review cycle

SPL Prescribing Information

• XML• Submit via folder• Submit thru ESG• Calendared events

NDC Labeler Code, Drug

Establishment, Drug Listing


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 waiver10. SPL ≠ PIM


How to Connect with Reputable Vendors & Resources

Assess your internal requirements & volumeCurrent/projected product portfolioLocations of manufacturing

Survey the vendor optionsIn-houseOutsource

Request for Information/Proposal (RFI/RFP)Plan for process reengineering



Questions & Discussion

Antoinette Azevedo, President & CEOe-SubmissionsSolutions.com

[email protected]://www.e-SubmissionsSolutions.com/

Telephone (619) 220-7081Fax (619) 220-0831

mailto:[email protected]

http://www.e-submissionssolutions.com/

Structured Product Labeling: Four Strategies to Comply ...Oct 13, 2010 · What is Structured Product Labeling? z. eXtensible Markup Language . z. Standard structure and encoding

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