TGA-eCTD format Submitting data – Australia-2024

Submitting data in the eCTD format – TGA – Australia-2024 , The following guidance is intended for sponsors and manufacturers interested in submitting data in the electronic Common Technical Document (eCTD) format for various types of products including prescription medicines, biological products, over-the-counter medicines, registered complementary medicines, assessed listed medicines, listed medicine ingredients, and master files. This document serves as a step-by-step guide for submitting an eCTD sequence to the TGA.

Step 1: eCTD format – TGA – Australia

Verify the Acceptance of eCTD Format Before proceeding, it’s essential to confirm whether the eCTD (electronic Common Technical Document) format is endorsed for use. eCTD is the preferred format for submitting applications concerning prescription medications. Additionally, it is suitable for various other categories, including:

• Biological products
• Over-the-counter medications
• Registered complementary medicines
• Assessed listed medicines
• Ingredients intended for listed medicines
• Master files

Step 2: eCTD format – TGA – Australia

Confirm Your Client ID If you haven’t obtained a Client ID yet, you’ll need to do so before proceeding. Follow the instructions provided on:

• TGA Business services: getting started with the TGA

The Client ID is a crucial element within the XML envelope for every sequence. It serves to group together all sequences originating from a single sponsor (client).

Step 3: Obtain an e-Identifier

If your medicine or biological product doesn’t have an e-Identifier (e-ID) already, you’ll need to acquire one. However, if you’re transitioning from Non eCTD electronic Submission (NeeS) to eCTD, you don’t need a new identifier;

just change the ‘n’ to an ‘e’ in your e-ID. For instance, from n012345 to e012345. The e-ID for eCTD always begins with an ‘e’.

Generally, an e-ID:

• is specific to a sponsor and active ingredient (or combination of active ingredients);
• encompasses all dosage forms, strengths, trade names, and manufacturers.

Should you require any deviations from this standard, reach out to the eSubmissions team using the contact box on the TGA electronic submissions page.

To obtain an e-Identifier, send an email to eSubmissions@health.gov.au with ‘Request for e-Identifier’ in the subject line. You’ll need your e-ID for Step 4.

In your email, include:

• Company name (associated with your Client ID);
• Names of active ingredient(s) (approved or proposed);
• Proposed application type, e.g., ‘Type A – New Chemical Entity’ or ‘Drug Master File’.

Step 4:

Compile and Publish the Sequence Compile and publish your sequence with assistance from your eCTD software vendor or consultant.

Populating Your XML Envelope In this step, populate your XML envelope. You’ll need to know:

• e-ID;
• Client-ID;
• Approved name(s) of the active ingredients;
• Trade name(s) (or proposed trade name(s)) – if no trade name is available, include the approved name in this field;
• Submission or application number(s);
• Sequence number;
• Related sequence number;
• Regulatory activity lead;
• Sequence type;
• Sequence description;
• Submission mode – currently always ‘single’;
• Contact email address;
• Current ARTG number(s), if applicable.

Compiling Your Sequence To facilitate compilation:

• Familiarize yourself with the eCTD specifications and validation criteria;
• Ensure all information within the XML envelope is accurate and complete. Errors can cause processing delays;
• Carefully select the most appropriate sequence type and sequence description for your application.

Publishing Your Sequence To aid in publishing:

• Refrain from making further changes to a sequence once published. Ad hoc post-publication alterations may lead to modified file validation errors and processing delays.

Data Requirements for Your Sequence Data requirements vary based on the type of therapeutic good and the application type. Refer to the relevant therapeutic area guidance for specifics.

Step 5: Validate the Sequence We strongly advise validating your sequence before submission. Validation errors and warnings can delay processing and evaluation of your data.

Validation Warnings Strive to eliminate validation warnings. If unavoidable, justify them in your sequence cover letter.

Validation Errors Address validation errors before uploading the sequence.

If you’re unsure about the validation of a sequence, contact the eSubmissions team at eSubmissions@health.gov.au before submission.

Step 6: Submit the Sequence to the eSubmissions Team For timely uploading of your sequence, send it to the eSubmissions team.

Submitting Your Sequence Sequences must be provided as a single zipped file, titled with the e-ID\sequence-number format, for example e123456\0002.

You can submit your sequence via:

• 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 and the application form supports this capability.

https://www.tga.gov.au/sites/default/files/submitting-data-ectd-format.pdf