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.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
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.
Posted 02 January 2013 | By Louise Zornoza,
Health Canada has opened a consultation regarding the new Prescription Drug List that is scheduled replace the existing Schedule F of the Food and Drug Regulations. The regulatory process to add or remove a drug from Schedule F will be replaced by an administrative process, requiring the amendment of all existing regulations and draft regulations that have been developed.
Health Canada has also prepared a draft guidance document that explains the principles and factors that the agency will consider when deciding whether a drug would best be sold as a prescription drug or a non-prescription product. A proposed Prescription Drug List provides a user-friendly format for human use and for veterinary use, but does not include ingredients listed in the Controlled Drugs and Substances Act Schedules.
A question-and-answer document has also been released to assist the public in understanding the changes mandated by the Jobs, Growth and Long-term Prosperity Act (Bill C-38), which received Royal Assent on June 29, 2012. The deadline for comments is 7 March 2013.
Read more:
Read all Breaking News from RegLink
Tags: Schedule F, pharmaceutical, guidance, drug, regulations
Regulatory Focus newsletters
All the biggest regulatory news and happenings.