The TGA has published  updated GMP Clearance Guidance (Version 18.4), and a new Sponsor Information Dashboard giving sponsors real-time information on GMP clearance processing timeframes providing industry with the best indication of how long an application will take. The Dashboard was initiated by the need to remove all references to GMP Clearance target timeframes, in acknowledgement that these timeframes are not currently being met for certain application types.

Based on TGA feedback at the TIWGG forum, this alert also includes some tips for industry on how to ensure Clearance applications are progressed as efficiently as possible.

Please read this tech alert for more details.