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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
Updated by a group of distinguished regulatory experts, this new edition is a must-have handbook for regulatory professionals at all levels.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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.
The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 31 July 2012 | By Ansis Helmanis,
Newly proposed safety-related revision from Canadian regulators will apply to acetylsalicylic acid (ASA)-containing products, and contains proposed limits for over-the-counter (OTC) use.
The product, more commonly referred to as aspirin, is increasingly found in combination products containing, for example, codeine and caffeine.
The draft proposal responds to adverse event reports concerning overdoses from products containing ASA, as well as risks to infant health posed by codeine use by nursing mothers. The draft guidance does not apply to products used by children under 12 years of age or for products used for cardiovascular protection or stroke prevention. The deadline for comments is 27 September 2012.
Read more:
Health Canada - Release of Draft Guidance Document: Acetylsalicylic Acid Labelling Standard
Get more Breaking News from RegLink
Tags: Draft Regulation, ASA, Aspirin
Regulatory Focus newsletters
All the biggest regulatory news and happenings.