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 18 June 2012 | By Ansis Helmanis,
A proposed new standard that defines the criteria for inclusion and exclusion of drugs in list of drugs used as the reference drugs by generics (Reference Listed Drug) was adopted by the Board of Brazil's national regulatory agency, Anvisa, on 14 June.
A key provision of the proposal would require the reference drug manufacturer to provide the drug for purchase by a generic company. The purpose of the provision is to ensure that generic companies can obtain the drug in order to conduct the bioequivalence testing needed for the registration of a generic version of the reference drug.
Generic companies now run into problems obtaining such drugs that are restricted to hospital use or are distributed only in specific programs.
Read more:
Anvisa - Health product may have the instruction manual online
Tags: Access, Generic, pharmaceutical, brazil, reference, drug, REMS
Regulatory Focus newsletters
All the biggest regulatory news and happenings.