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 email@example.com 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.
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 01 October 2012 | By Ansis Helmanis
Health Canada announced on 28 September the expansion of its pilot project on the use of drug review assessment information from foreign regulatory agencies, such as the European Medicines Agency, in its own marketing authorization review process.
The Use of Foreign Reviews pilot project was first initiated in October 2011 to test whether access to such data would assist Health Canada in meeting its regulatory assessment "targets" by speeding up the application review process.
The pilot will be extended through 31 March 2013 and expanded to include Notifiable Changes (drugs), Risk Management Plans (drugs), Periodic Safety Update Reports and evidence provided to confirm the continued safety and effectiveness of a marketed product (drugs and medical devices).
In addition, the following data packages will also be included:
Comments on the revised draft guidance may be submitted until 31 March 31 2013.
Health Canada - Draft Guidance Document: The Use of Foreign Reviews by Health Canada and revisions to the Use of Foreign Reviews pilot project
Health Canada - Frequently Asked Questions (FAQs) - The Use of Foreign Reviews by Health Canada
Health Canada - Foreign Review Attestation and Summary of Quality Differences: Subsequent Market Entry Products (Human Drugs)
Read all Breaking News from RegLink
Tags: Foreign Data, data, review, pilot program
Regulatory Focus newsletters
All the biggest regulatory news and happenings.