TGA Guidance: Submitting data in the eCTD format

Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data in the eCTD format" which guides how to submit data in the electronic Common Technical Document (eCTD) format.

In this guide, TGA provides step-by-step instructions on how to submit an eCTD sequence to the TGA and these instructions are for sponsors and manufacturers submitting data in the electronic Common Technical Document (eCTD) format for:

1. prescription medicine;

2. biological;

3. over-the-counter medicine;

4. registered complementary medicine;

5. assessed listed medicine;

6. listed medicine ingredients;

7. master file

In order to submit your data in the eCTD format, the applicant needs to follow the below steps

• Step 1: Check that eCTD is an accepted format

• Step 2: Ensure you have a Client ID

• Step 3: Get an e-Identifier (e-ID)

• Step 4: Compile and publish the sequence

• Step 5: Validate the sequence

• Step 6: Send the sequence to the eSubmissions team

The sequences must be provided as a single zipped file with the e-ID (e.g. e123456), and they can be submitted through:

• email for submissions under 30MB uncompressed.

• post in a USB or non-rewritable CD or DVD;

• the TGA Business Services (TBS) portal as an attachment to an application, if less than 100MB

Click this LINK to know more in detail about the stepwise details on how to submit data in the electronic Common Technical Document (eCTD) format.