Health Authority: Therapeutic Goods Administration (TGA)
eCTD, Accepted Since: Late 2014
eCTD Version: Module 1 Specification v3.3, M2-M5 – v3.2.2 and M1-M5 – v4.0
Types of Applications
Market Authorization Applications (MAA)
Process to be followed to make a TGA eCTD submission
- 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.
- Sponsors and applicants are free to use any appropriate software to compile and publish TGA 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.
- 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