Drug eSubmission Project

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Drug eSubmission Project
Thursday 17th July 2014
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Outline

• Objectives
• What eSubmission brings to Thailand?
• Why eCTD
• The Pilot
• Timeline
• Impact to current application process
• What will future bring

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What eSubmission brings to Thailand?

• Prestige project to be first country to publish a
  national eCTD specification in ASEAN.
• Countries with eCTD specification have increased
  access to medicine through ease of submitting
  (part of first or early wave of release).
• Increases abilities to collaborate with other
  agencies world wide.
• Enables local industries to better compete in the
  international market place (promotes export).
• Increase the quality of review by providing
  transparent review process and immediate access
  to relevant information .

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Why eCTD?

• Consider as Global submission strategy
• eCTD acceptance worldwide
• Establish a single application format for all
  applications
• Timelines meet or beat paper timelines
• Support Lifecycle Management
• Improve Reviewing Process by harmonizing
  structure.
• There are minor differences between ACTD and eCTD

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Improve Reviewing Process

• Submission are uploaded via electronic submission
  gateway (future) and can be available to
  reviewers within minutes
• Improves application review process
• More efficient review
• Changes and update are easy for reviewers to
  identify and review
• Bookmarks and Hyperlinks
• Easy 24/7 access from any location
• Everyone can access the document simultaneously
• Document is more secure, no need to print desk
  copies, maintain duplicate electronic file

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The Pilot

• Working with industry representatives to identify
  suitable eCTD pilot submissions
• Only electronic submission will be received.
• Testing various aspects of system before full
  adoption in 2015.
• Looking to test the following application types
• new chemical entity
• new biological
• new generic
• submissions prepared with different publishing
  tools

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Criteria for Participation

• Contact the FDA by 31 July 2014
• Request consideration
• Decisions will be made on case by case due to
  Project resources and budgeting
• Fits scope of initial preparations
• Industries who are not in the pilot can
  participate in the next phase.

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Close of Initial Feedback

• 30 September 2014
• Feedback will be collected from three general
  sources
• Pilot Participants
• Industries in General
• FDA Internal
• Feedback to be reviewed, approved and integrated
  into documentation updates for official release
  in Q1 2015

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Publish eCTD Specification

• Documents are published on http//http//drug.fda.
  moph.go.th/
• TH Module 1 and Regional Specification which base
  on EU eCTD(V.3.2)
• TH Regional Specification and Validation Criteria

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Public Hearing and Specification QA

• Public Hearing on Pilot Project
• Industries aware of upcoming change
• Question and Answer session of eCTD Specification

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System Implementation

• System is installed at FDA under secure firewall
  and inline with IT Security standard
• System will be tested and qualified the readiness
  by FDA

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Reviewer Training

• To understand change of reviewing process in the
  system

Industries eCTD compilation

• To gain sound understanding of eCTD Specification
  and compilation
• Hand on workshop is limited to pilot group.

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eCTD is accepted(Pilot)

• Pilot Groups can start submitting eCTD
  applications
• Initial feedback of application verification will
  be right on spot!
• Internal Reviewing process is started once
  application is verified!

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eCTD is accepted(Public)

• Industries can start submitting eCTD applications
  after system is heavily tested by pilot group and
  reviewers.
• Initial feedback of application verification will
  be right on spot!
• Full electronic review processes are implemented.

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Impact to current application process

• There is no impact to other or existing
  applications and variations.
• ACTD can be submitted in paper form. The
  electronic submission will be considered in 2015.

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What will future bring

• FDA is working with other regulators for
  continuous improvement and continuing implement
  these as best practice.
• eSubmission gateway will be implemented to
  support application process through internet.
• Improve bi-directional communication over
  electronic communication channel.
• Only eSubmission will be received by 2017
• Prepare for next iteration of eCTD 4.0 (RPS)
• RPS(Regulated Product Submission) is able to
  support different types of application e.g. ACTD,
  Medical Devices, Veterinary

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• Thank you for your attention