CTD Quality Consulting

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Managing the Drug DevelopmentProcess with eCTD
ToolsAdvantages of Preparing Submissions
Electronically

• Michelle Herrera Foster, Ph.D.
• June 9, 2005
• RAPS Boston Seminar

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ICH M4
NOT Part of the CTD
RegionalAdminInformation
Module 1
The CTD
QualityOverallSummary
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The Common Technical Document (CTD)

• Required in EU, Japan, and Canada for marketing
  applications also for DMF in EU, Canada
• Highly recommended by FDA for NDA, BLA
• FDA follows ICH guidance
• Good Guidance Practices (9/00) require that CTD
  not be mandatory
• Required in EU (IMPD) and Canada for
  investigational applications accepted by FDA
  for IND
• Required for eCTD submissions

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What are the advantages of the CTD?

• Global harmonization of applications
• Provides standards to prepare submission-ready
  documents in the IND phases
• Standardization assists project management and
  information management
• Facilitates life cycle management
• Facilitates drug development planning

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Presentation Topics

• Regulatory Challenges and Transitions
• Taking Advantage of New Standards
• Content Management in Drug Development
• Document Management per the CTD
• Building the NDA from Phase 1
• Mapping and Gap Analysis
• Electronic Tools and their Benefits

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Regulatory Challenges and Transitions in Drug
Development

• Transitioning to the CTD
• Requirement for electronic labeling (SPL)
• Preparing for the eCTD
• Life Cycle Management
• Quality Systems

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Electronic Labeling (SPL)

• Structured Product Labeling (XML-based)
• Supports electronic distribution/update over the
  life cycle of the drug
• Electronic labeling to be required by FDA 10/05

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Taking Advantage of New Standards

• How to cope with evolving regulatory standards
  and get them to work in your favor
• And work more Efficiently

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The Benefits of New Standards
CTD
Global harmonization, submission-ready structure
eCTD, SPL
XML technology, content management
Life Cycle Management
Change control, regional differences
Quality Standards
Quality and Regulatory planning hand-in-hand
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Quality Systems ApproachFDA draft guidance 9/04

• Monitoring of Trends
• Risk Assessment
• Corrective Action
• Preventive Action
• Process Analytical Technologies Guidance
• Increased government-mandated structure can be
  used for better control of the process

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Preclin Ph 1 Ph 2 Ph 3 NDA Information
Management
Doc Management
Functional Area
CMC
Development Docs
GLP Docs
Nonclinical
GCP Docs
GMP Docs
Clinical
Submission Docs
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Information Management in Drug Development

• Why not manage your documents to meet every
  product development need, organized by regulatory
  approval categories?

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Document Management per the CTD, in DP
Manufacture
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Building the NDA from Phase 1
P.1 P.2 P.3 P.4 P.5 P.6 P.7 P.8
S.1 S.2 S.3 S.4 S.5 S.6 S.7
Development Plan
Pre-IND
IND
NDA, DMF
Post-Approval
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Submission-Ready Documents

• Summary ? Module 2
• Body of report ? Module 3, 4, or 5
• Appendices ? For the file
• Build the NDA from Phase 1

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Mapping and Gap Analysis

• Map documents to the CTD
• Perform a gap analysis for each stage of drug
  development
• Define action items
• Assign tech leads
• Track progress

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CTD Quality MAPExample
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Action Items

• Submission Requirements
• Risk Reduction
• Quality Systems
• Pre-Approval Inspection

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The Overlap of Regulatory and Quality Systems
S.2, P.3
Mod 1 P.3
A.1
S.2.3, P.4, S.6, P.7
S.4, P.4, P.5
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Benefits of Electronic Tools

• Submission-Ready docs, Gap Analysis ?
• Build the NDA from the IND ?
• Filing/Version Control ?
• Project Management ?
• SPL requirement ?
• eCTD submission ?

• CTD Templates
• eCTD structure
• Document Management
• Link documents to project management software
• XML editor and template
• Reviewer Tools
• Life Cycle Management

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CTD Templates

• Structure guide (DTD)
• Format/style guide
• Detailed Content
• Regulatory guidelines ICH, regional
• Table shells
• Instructions to authors
• Granularity Sub-headings
• XML Features
• Tagging, linking
• eCTD Compatible

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Bottom-Up Drug Product Development
CTD, eCTD
Workflow Process Management
Submission-Ready Documents Content Management
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Conclusions

• Electronic tools provide many benefits in
  planning and preparing regulatory submissions,
  and managing complex content
• Drug development planning benefits from
  application of e-document tools,
  from the IND to the NDA
• XML standardization helps you control your drug
  development process
• XML tools can be phased in

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References

• ICH International Conference on Harmonization
  www.ich.org
• FDA Food and Drug Administration (U.S.)
  www.fda.gov
• EMEA European Medicinal Evaluation Agency (EU,
  Europe), www.emea.eu.int
• Michelle_at_ctdquality.com 978-922-6017
• www.ctdquality.com