positions available now

A summary of the TGA’s Literature Based Submission changes

The Therapeutic Goods Administration has updated their ‘points to consider’ publication (dated 2003) regarding the submission of literature-based data in support of prescription and OTC medicine registration in Australia. It is important that anyone wishing to pursue a Literature Based Submission strategy consult these new requirements.

The new document better defines the regulatory pathway, provides more certainty around dossier requirements and avoids ineffective Pre-Submission Planning Form or dossier rejection. The document also provides more instruction regarding search methodology.

Some of these requirements will have significant impact on the timing of your pre-submission lodgement plans. As such, it would be best to incorporate these regulatory requirements as early in your development process as possible.

Our Regulatory Services Manager, Jeanette Lodge, has summarised the Literature Based Submission changes for you.

Download the Commercial Eyes summary: May 2014 Changes to TGA Literature Based Submission Guideline

This entry was posted in Life Sciences Industry, Regulatory Services, TGA and tagged , .
Copyright © 2020 Commercial Eyes