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.
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 08 March 2012 | By Alexander Gaffney, RAC
The European Medicines Agency (EMA) released a concept paper on 8 March about the need to revise current labeling guidelines for medicines containing excipients.
Current guidelines contain warnings about the presence of certain excipients, particularly those pursuant to 2001/83/EC Article 54(d) which states that all excipients must be declared if a product is an injectable product or eye preparation. Further, all excipients know to have an action or effect on the body must be declared.
The concept paper notes the need to expand beyond this limited labeling regulation to encompass additional products, information and populations, including pediatric populations, pregnant women and additional routes of product administration.
EMA recommends that the current guideline be revised to take these considerations into account.
Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00)
Tags: Pregnant, Excipients, Concept Paper, Pediatric, Latest News
Regulatory Focus newsletters
All the biggest regulatory news and happenings.