Regulatory Support for TGA eCTD Submissions

Overview

Starting November 01, 2021, the Therapeutic Goods Administration (TGA) will begin a phased transition to Electronic Common Technical Document-only (eCTD Submissions) for all prescription medicines.

The Electronic Common Technical Document (eCTD) is a specification for the pharmaceutical industry to submit electronic applications to enter registered medicines into the Australian Register of Therapeutic Goods (ARTG) and is organised according to the current Australian and ICH eCTD specifications.

The information is for sponsors and manufacturers willing to submit data in the eCTD format for a:

  • Prescription medicine
  • Biological drug
  • Over-the-counter medicine
  • Registered complementary medicine
  • Assessed listed medicine
  • Listed medicine ingredient
  • Master file

Product Type

Timelines

New Chemical Entity Medicine (Type A)

November 01, 2021 - Stage-1

New Biological Entity Medicine (Type A)

New Biosimilar Medicine (Type A)

New Combination Medicine (Type B)

Extension of Indication Medicine (Type C)

June 01, 2022 - Stage-2

Major Variation Medicine (Type F)

New Generic Product (Type D)

Remaining Prescription Medicine Including Master File

November 01, 2022 - Stage-3

 

Freyr Expertise

  • Maintaining eCTD compliance as per the TGA requirements
  • Paper to eCTD electronic regulatory submission conversions
  • Develop knowledge repository for regional requirements across the globe
  • Periodic training and updates on the ever-changing global Regulatory requirements
  • Gap analysis to create the process aids and charts
  • Continuous project monitoring
  • Periodic quality check for effective time management
  • Detailed tracker creation to track all the version changes made through the publishing lifecycle
  • Freyr SUBMIT PRO – an in-house Regulatory eCTD publishing and submissions tool equipped with the latest TGA eCTD Template version (3.2.2)

Freyr Advantages

  • A team of globally qualified eCTD, NeeS and paper publishing and submission experts
  • A robust eCTD publishing and submission software designed with an intuitive workflow, eCTD viewer and an in-built validator complying with 21 CFR part 11 requirements
  • eCTD submission roadmap right from compiling original submissions to maintaining lifecycle management
  • Regulatory resource allocation support
  • Report level publishing, document-level publishing and submission level publishing
  • Error-free submissions that enable your organization to focus on core business functions
  • Two-stage quality check process
  • 24x7 global delivery model with quick turn-around-time

For faster, compliant and seamless submissions, Freyr offers an in-house eCTD tool Freyr SUBMIT PRO. Freyr SUBMIT PRO suits all your submission requirements across the globe and supports regional formats. To know more about Freyr SUBMIT PRO, gain a comprehensive overview at

www.ectdtool.com

Location

903/50 Clarence St,
Sydney NSW 2000
(9th level of building 50)

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