Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 12 June 2012 | By Alexander Gaffney, RAC
Australia's Therapeutic Goods Administration (TGA) announced on 12 June the impending release of proposed changes to how sponsors of registered prescription medications can make "minor variations" to the medicine's entry in the Australian Register of Therapeutic Goods (ARTG).
TGA said the changes typically fall under one of four categories: corrections to the entry, a safety-related changes, "self-assessable" quality-related changes or Category 3 quality-level changes. The agency said in a statement it hopes the proposed change will decrease the time necessary to make changes, increase regulatory certainty and "improve the transparency of TGA processes."
A consultation on how to implement the changes is planned for August and September of 2012, with final implementation occurring by November 2012.
Read more:
TGA - Process review: minor variations to prescription medicines - for sponsors
Tags: Minor Variations, Consultation, Latest News, Changes, australia, proposed