Invitation to comment: Sterilisation and Substantial changes

The Therapeutic Goods Administration (TGA) is requesting your comments on the following documents regarding Sterilisation and Substantial changes.

Background
The TGA guidance 'Checklist guidance to supporting data required for adding or changing sterilisation suppliers for TGA conformity assessment applications' provides additional detail on the documentation required for applications relating to sterilisation supplier changes. It is acknowledged that incomplete or inadequately prepared submissions can further lengthen TGA's review process.

We look forward to your thoughts. Please submit your response to policy@adia.org.au by close of business Monday, 11 May 2020. Feedback will then be compiled and submitted on Wednesday, 13 May 2020.