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.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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 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.