TGA eCTD

Australia

Country: Australia
Health Authority: Therapeutic Goods Administration (TGA)
eCTD, Accepted Since: Late 2014
eCTD Version: Module 1 Specification v3.3 and M2-M5 – v3.2.2

Types of Applications

Market Authorization Applications (MAA)

Process

  • eCTD submissions will be submitted via electronic media. A future project phase will examine portal requirements.
  • It is envisaged that registered non-prescription medicine submissions can continue to use the eBS portal as is used currently. This will be confirmed in initial testing.

Agency Recommendations

  • Sponsors and applicants are free to use any appropriate software to compile and publish eCTD submissions. The TGA also requires a validation report to be attached to each submission. Submissions must pass the TGA’s validation processes to be accepted.
  • TGA does not recommend any specific eCTD tools. However, there are a number of software vendors in the marketplace.

Challenges

  • Requires cutting-edge technology and seasoned staff
  • Not all the content is in a standard format. Hence standardization is required
  • Difficult to implement last minute changes
  • Local affiliates have limited access to create or customize
  • Baseline submissions are costly and likely to be of limited value
  • Lifecycle management
  • Consolidated approach to drafting of dossier

How can Freyr help?

  • Guarantee your ROI with an eCTD software that optimizes cost-per-submission
  • Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
  • eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
    For more information on the same, consult us

Other Countries

USA, EU, Health Canada, Switzerland, South Africa, EAEU, Jordan, Thailand, GCC, ASEAN

References