Upcoming regulatory submission mandates 2017
- 1. © 2017 Cunesoft GmbH 1 Ready or Not? Get Ahead of Upcoming Regulatory Submission Mandates
- 2. © 2017 Cunesoft GmbH 2 3 Q&A Session What’s different about eCTD: Introducing Cunesoft • The terminology • How you prepare and manage your documents • How you create your submission • How you verify your submission • How you send your submission • How your submission lives on • Recommended actions 1 2 Index
- 3. © 2017 Cunesoft GmbH 3© 2017 Cunesoft GmbH 3 „Regulatory peace of mind“ Jim Nichols VP, Life Sciences NA Introducing Cunesoft Headquarters: Munich, Germany Regional Offices: Paris, Bangalore, Princeton Industry Focus: Regulatory Software for Life Sciences Venture Partners: HTGF, Bayern Kapital, Occident Group Corporate Facts Global Life Sciences Customer
- 4. © 2017 Cunesoft GmbH 4 POLL What is your level of experience with eCTD? • I’ve never created an eCTD • I am currently planning my first eCTD • I have created 1 eCTD • I have created more than 1 eCTD
- 5. © 2017 Cunesoft GmbH 5© 2017 Cunesoft GmbH 5 Submission Road Map Europe US Canada 2017 2018 2019 All Submissions in CP and new MAA in DCP and MRP (human) in eCTD All MRP submission in (human) eCTD All new MAA in NP (human) in eCTD All other NP submissions in eCTD (human) All new NP submission in eCTD (human) All other MPR and all NP submissions in eCTD (human) All submissions (human) in CP, DCP, MRP and NP in eCTD Mandatory Mandatory Optional Optional NDA, ANDA, BLA in eCTD Format Commercial IND Master files in eCTD Format NDA, ANDA, BLA in eCTD Format Commercial IND Master files in eCTD Format Regulatory activities for the following currently remain out of scope for filing in eCTD format; they must be filed in “non-eCTD electronic-only”: Medical Devices, Veterinary Drugs Master Files, Clinical Trial Applications (eCTD CTA pilot only), Drug Identification Number (DIN) Applications and Post-Authorization Division 1 Changes (PDC) for Human drugs in eCTD All submissions in NDS, SNDS, ANDS in eCTDAll submissions in NDS, SNDS, ANDS in eCTD
- 6. © 2017 Cunesoft GmbH 6© 2017 Cunesoft GmbH 6 Key Differences The terminology How you prepare and manage your documents How you create your submission How you verify your submission How you send your submission How your submission lives on
- 7. © 2017 Cunesoft GmbH 7© 2017 Cunesoft GmbH 7 The CTD Triangle https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf Common Technical Document
- 8. © 2017 Cunesoft GmbH 8© 2017 Cunesoft GmbH 8 What’s The Difference? The Common Technical Document (CTD) is a set of specifications for application dossier for the registration of Medicines and designed to be used across Europe, Japan, United States, Canada, Australia, Saudi Arabia and South Africa. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. CTD The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. eCTD
- 9. © 2017 Cunesoft GmbH 9© 2017 Cunesoft GmbH 9 The Terminology What an eCTD submission is NOT It is NOT an XML file that you write It is NOT a single document you send What an eCTD submission IS It is a collection of documents (called leaf files) organized into a defined structure of folders (nodes) Documents are aligned to the CTD Model (granularity) The submission has XML files that describe the purpose of the submission (the envelope) and the context of the documents (the backbone) Each eCTD submission (sequence) builds upon previous submissions following a lifecycle
- 10. © 2017 Cunesoft GmbH 10© 2017 Cunesoft GmbH 10 Module Node Leaf
- 11. © 2017 Cunesoft GmbH 11© 2017 Cunesoft GmbH 11 Example of eCTD for Canada The Package Delivered The Lifecycle View
- 12. © 2017 Cunesoft GmbH 12© 2017 Cunesoft GmbH 12 Your Documents Think about your documents as individuals You are not submitting one large document anymore Consider document ownership and authoring Who writes? Determine if review and approval is needed for documents Who reviews? Think about the original source documents
- 13. © 2017 Cunesoft GmbH 13© 2017 Cunesoft GmbH 13 Your Documents Use templates • Document templates aligned with the CTOC and expected granularity make authoring easier Consider the source • Leaf files are typically PDFs but starting with Word documents makes it easier • Internal links • TOCs Remember navigation • Within and between documents using hyperlinks and bookmarks Author with style • Define your corporate authoring style for • Fonts, margins, headers, footers, naming Scanned documents require OCR
- 14. © 2017 Cunesoft GmbH 14© 2017 Cunesoft GmbH 14 Documents Align with CTOC https://www.fda.gov/downloads/drugs/ucm163175.pdf
- 15. © 2017 Cunesoft GmbH 15© 2017 Cunesoft GmbH 15 Bookmarks & Hyperlinks Ease Navigation Intradocument navigation Intra- and inter-document navigation
- 16. © 2017 Cunesoft GmbH 16© 2017 Cunesoft GmbH 16 Start Where You Left Off 1 2 3 4 (sequence 0001) In most cases, you do NOT need to resubmit your existing documents
- 17. © 2017 Cunesoft GmbH 17© 2017 Cunesoft GmbH 17 Your Submission You’ll need a smart solution The only eCTD system with a built in virtual eCTD assistant VERA - Virtual Electronic Regulatory Assistant • Offers you pre-defined templates to follow • Automatically creates the underlying backbone, envelope and (if necessary) study tagging files (STF) • Works seamlessly with your document management system • Can determine the context of your documents in the submission • New, Replace? • Will check your documents for possible compliance issues • Hyperlinks, bookmarks, PDF settings • Allows you to publish incrementally or iteratively • Guides you along the way!
- 18. © 2017 Cunesoft GmbH 18© 2017 Cunesoft GmbH 18 Built-in Templates
- 19. © 2017 Cunesoft GmbH 19© 2017 Cunesoft GmbH 19 Seamless between DMS and eCTD
- 20. © 2017 Cunesoft GmbH 20© 2017 Cunesoft GmbH 20 Check your work
- 21. © 2017 Cunesoft GmbH 21© 2017 Cunesoft GmbH 21 Incremental Publishing
- 22. © 2017 Cunesoft GmbH 22© 2017 Cunesoft GmbH 22 Autogenerates all files
- 23. © 2017 Cunesoft GmbH 23© 2017 Cunesoft GmbH 23 Submission Validation Understand submission validation • What is used by the health authority to whom you’re submitting? • Obtain the same tool Check your submission • Validate your submission prior to transmission • Address any problems identified
- 24. © 2017 Cunesoft GmbH 24© 2017 Cunesoft GmbH 24 Sending Your Submission Get to Know Your Gateways • FDA: Electronic Submission Gateway • Health Canada • Europe Other Countries • Australia - DVD • South Africa – CD/DVD • Saudi Arabia – CD/DVD • Thailand – CD/DVD Gateways often require days-to-weeks of time for getting established. Plan ahead !
- 25. © 2017 Cunesoft GmbH 25© 2017 Cunesoft GmbH 25 The Life(cycle) of Your Submission Once you start, you keep going • Each sequence builds on the prior activities • Documents can be replaced or withdrawn • To see everything, you need a Viewer • Comparative • Cumulative You can repurpose from one region to another • Start a new region based on another region’s cumulative activity
- 26. © 2017 Cunesoft GmbH 26© 2017 Cunesoft GmbH 26 DMF Submissions in eCTD Your first submission is about your overall DMF • Your SUBMISSION equals your DMF # (aka Application #) • The SEQUENCE is about its purpose • The CONTENT communicates the documents Your NEXT submission is the NEXT SEQUENCE • Not a ‘new submission’ Submission Sequence Content 009996 (ie DMF #) Sequence 0001 Sequence 0002 Cover Letter Cover Letter LOA LOA
- 27. © 2017 Cunesoft GmbH 27 POLL How do you now feel about your readiness for the move to eCTD? • I’m still scared • I feel better • You’ve confirmed my knowledge
- 28. © 2017 Cunesoft GmbH 28© 2017 Cunesoft GmbH 28 https://www.fda.gov/downloads/Drugs/D evelopmentApprovalProcess/FormsSubmi ssionRequirements/ElectronicSubmissions /UCM446272.xls https://www.fda.gov/downloads/Drugs/G uidanceComplianceRegulatoryInformation /Guidances/UCM333969.pdf https://www.fda.gov/forindustry/electroni csubmissionsgateway/ucm114831.htm http://www.hc-sc.gc.ca/dhp- mps/prodpharma/applic- demande/guide-ld/mf-guide-ld-fm- eng.php https://www.canada.ca/en/health- canada/services/drugs-health- products/public-involvement- consultations/drug- products/harmonisation-guidelines- registration-pharmaceuticals-human- use.html Useful Resources Health Canada FDA EMA http://esubmission.em a.europa.eu/ectd/
- 29. © 2017 Cunesoft GmbH 29© 2017 Cunesoft GmbH 29 Your Questions
- 30. © 2017 Cunesoft GmbH 30© 2017 Cunesoft GmbH 30 Regulatory Master Data Management eCTD Submissions Regulatory DMS Become A Happy Customer ! Email: info@cunesoft.com DE-Tel: +49 (0)89 235 14 741 US-Tel: +1 (609) 955 34 68