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.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 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
Regulatory Focus newsletters
All the biggest regulatory news and happenings.