Submitting data in the NeeS format – TGA -Australia

The following guidance is intended for sponsors and manufacturers interested in providing data in the NeeS format for various types of products, including prescription medicines, biologicals, over-the-counter medicines, registered complementary medicines, assessed listed medicines, listed medicine ingredients, and master files.

This version 1.1 of the guidance, dated March 2021, offers a detailed, step-by-step approach to submitting a NeeS sequence to the TGA.

However, it’s important to note that this guidance does not address the application process or specify the exact data required within your sequence. eCTD

1. 1. Prescription Medicine: This refers to medications that can only be dispensed with a prescription from a licensed healthcare professional. These drugs are typically more potent or have a higher risk of side effects and require professional oversight.

1. 1. Biological: Biological products are derived from living organisms or their components. This category includes vaccines, blood and blood components, allergenic products, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins.

1. 1. Over-the-Counter Medicine: These are medications that can be purchased without a prescription and are generally considered safe for use without medical supervision. Examples include pain relievers, antacids, cough and cold medicines, and topical creams.

1. 1. Registered Complementary Medicine: Complementary medicines are products used alongside conventional medical treatments and include vitamins, minerals, herbal remedies, traditional medicines, homeopathic preparations, and certain nutritional supplements. Registration indicates that these products have met specific regulatory requirements.

1. 1. Assessed Listed Medicine: Listed medicines are low-risk, complementary healthcare products that are listed on the Australian Register of Therapeutic Goods (ARTG). Assessed listed medicines undergo a higher level of scrutiny and assessment by the Therapeutic Goods Administration (TGA) before being listed on the ARTG.

1. 1. Listed Medicine Ingredient: This refers to the individual substances or components used in the formulation of listed medicines. These ingredients are subject to regulation and must comply with relevant standards and guidelines.

1. 1. Master File: A master file is a comprehensive document that contains detailed information about the manufacturing, processing, quality control, and testing of a pharmaceutical product or its components. It is typically submitted to regulatory authorities and can be referenced by multiple applicants without disclosing proprietary information.

Regarding the guidance provided: NeeS format

Step-by-Step Guide on Submitting a NeeS Sequence to the TGA: This guidance document outlines the process and requirements for submitting data in the Non-eCTD electronic Submission (NeeS) format to the Therapeutic Goods Administration (TGA) of Australia. It likely includes instructions on formatting, document organization, file naming conventions, and technical specifications for electronic submissions.

Exclusions: The guidance specifies that it does not cover the application process, which involves the overall process of applying for regulatory approval of a therapeutic product or ingredient. Additionally, it does not detail the specific data elements or content required within the NeeS sequence, leaving this aspect to be determined by other regulatory documents or guidelines.

This guide offers a step-by-step process for submitting a NeeS sequence to the TGA. However, it does not encompass details regarding the application process or the specific data requirements within your sequence.

Here’s the rephrased version: NeeS format

Guidance Overview: This guidance provides a systematic approach to submitting a NeeS sequence to the TGA. It’s important to note that this guide does not delve into the application process or the specific data prerequisites for your sequence.

Process Outline: To submit your data in the NeeS format, follow these steps:

Step 1: Confirm NeeS Acceptance: Check if NeeS is an accepted format by the TGA.

Step 2: Obtain a Client ID: Ensure you have a Client ID, which is essential for the submission process. If you don’t have one, follow the instructions provided.

Step 3: Acquire an e-Identifier: Obtain an e-Identifier if your medicine or biological product doesn’t have one already. Details for obtaining an e-Identifier are provided, including necessary information for the request.

Step 4: Compile and Publish the Sequence: Compile your NeeS sequence manually or through suitable software. Populate the Australian NeeS envelope form XML with the required information, ensuring accuracy and completeness. Additionally, consider the recommended practices for compilation and ensure sequential progression of sequence numbers.

Step 5: Validate the Sequence: Before submission, validate your sequence to address any validation warnings or failures. This step is crucial to prevent processing delays. Any unresolved issues should be justified in the sequence cover letter.

Step 6: Submission to the eSubmissions Team: Send your sequence to the eSubmissions team for timely processing. Ensure that your sequence is submitted correctly, following the provided guidelines for file formatting and submission methods.