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.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray 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. Either RAC exam (Devices and Drugs) 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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 03 September 2015 | By Zachary Brennan
Although the Australian regulator admits that it's still seeing extended processing timelines, the Therapeutic Goods Administration (TGA) says that it has cut the average time taken to evaluate a mutual recognition agreement (MRA) GMP clearance application by about 10 weeks since June.
Back in May 2011, TGA began mandating that Good Manufacturing Practice (GMP) clearance applications were required for all medicines supplied in Australia. As part of that process, TGA put out two guidance documents for sponsors who rely on overseas drug manufacturers in order to provide more information about what is an acceptable form of evidence to confirm GMP compliance, and how to submit such an application.
TGA lays out a number of requirements in the guidance and said it expects sponsors to "remain vigilant" in ensuring the regulatory compliance of the overseas manufacturing sites they use.
Between 2011 and 2015, the number of overseas manufacturers increased dramatically and TGA says the number of GMP Clearance applications has more than doubled. In 2014-15 a total of 5,384 applications were received, which compares with 4,222 applications in 2013-14 and 2,418 in 2010-2011.
"This has created a backlog of applications and has extended processing times. To address this, we have focused on reducing the largest part of the backlog, namely applications for manufacturers located in countries with whom Australia has Mutual Recognition Agreement (MRA applications)," the TGA said.
And now TGA is reaping the rewards of those efforts as the average time taken to complete an MRA GMP Clearance application has fallen from 16 weeks in June 2015, to an average of six weeks as of 14 August 2015.
Furthermore, analysis of the GMP Clearance applications processed shows that 90% of the MRA applications finalized in the week of 12 to 17 June 2015 were completed within 24 weeks of payment receipt, whereas 90% of the applications finalized in the week of 13 to 17 July 2015 were completed within 19 weeks of payment receipt. And as of 14 August 2015, 90% of the MRA applications are being completed within 11 weeks of payment receipt.
"To allow tracking of our progress on reducing the backlog, we have started gathering data relating to the total processing time (from the date payment is receipted to the date GMP clearance is issued) for each MRA application finalised since mid-June 2015," TGA says.
TGA
Tags: GMP
Regulatory Focus newsletters
All the biggest regulatory news and happenings.