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 firstname.lastname@example.org if you need assistance.
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.
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. 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.
Posted 21 March 2012 | By Alexander Gaffney, RAC
Health Canada is allowing unapproved drugs into the country on a short-term, controlled basis in order to alleviate recent drug shortages, reports The Ottawa Citizen.
"Under the special access program, the federal drug regulator has the power to grant the limited sale of unapproved drugs to physicians treating select patients with 'serious or life-threatening conditions,'" wrote TheOttawa Citizen.
Health Canada has reportedly approved 17 requests under the special access program, with another five requests still being processed by the agency.
Unapproved drugs are only temporarily approved for distribution if they have been approved in other countries by a "trusted regulator," including the US Food and Drug Administration (FDA), which has put in place a similar program to ease shortages of Doxil and methotrexate.
Ottowa Citizen - Sandoz says it won't price-gouge during drug shortage
Regulatory Focus - US FDA Importing Unapproved Drugs to Ease Shortages
Regulatory Focus - Canadian Drug Shortages Lead to Calls for Regulation
Regulatory Focus - Health Canada Accelerating Approvals to Ease Drug Shortages
Tags: Special Access Program, Shortages, Latest News, Drug Shortages, pharmaceutical, drug
Regulatory Focus newsletters
All the biggest regulatory news and happenings.