10 Small Submissions
No more than 10 Documents per submission
Australia TGA eCTD
Country: Australia
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.
Agency Recommendations
- Sponsors and applicants are free to use any appropriate software to compile and publish TGA eCTD submissions. The TGA eCTD submission also requires a validation report to be attached to each eCTD submission. eCTD 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 to make a TGA eCTD submission:
- 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 to make a TGA eCTD submission?
- 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, NMPA
