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.
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.
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 RAPS store will be under maintenance Saturday, 7 December between 6 AM and 12 PM. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 04 April 2013 | By Louise Zornoza,
Brazil's National Health Surveillance Agency (Anvisa) has proposed the formation of an electronic tracking system for drugs that would follow a drug from the point of manufacture to its dispensation to a patient.
The proposal was outlined in a consultation announced by Anvisa on 4 April 2013.
The proposed tracking system is to be based on the two-dimensional barcode, the Datamatrix, which will be included on sales packaging as well as secondary packaging such as pill packs and hospital packs.
According to the CEO of Anvisa, Dirceu Barbano, "Companies holding registration with Anvisa will be responsible for placing on each package a Unique Drug Identifier (IUM) formed by the drug registration number for the product containing thirteen (13) digits, plus the serial number, expiration date and lot number."
The drug industry would have 180 days to comply with the new requirement and retail sales outlets would have 360 days. The comment period will be open from 10 April through 9 May 2013.
Tags: brazil
Regulatory Focus newsletters
All the biggest regulatory news and happenings.