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.
Posted 16 August 2013 | By
Brazilian President Dilma Rousseff has signed the Brazilian Clean Companies Act (BCCA), which for the first time subjects Brazilian and foreign entities having a registered office in Brazil to civil and administrative sanctions for bribing either Brazilian or foreign public officials. Though not specifically targeted as the life sciences sector, the new law will have implications for all companies doing business in that Brazil.
The BCCA prohibits the bribery of domestic and foreign public officials. Bribery is defined in the Act to include promoting, offering or giving, "directly or indirectly, an improper benefit to a public agent or a third person related to him [or her]."
Unlike the US Foreign Corrupt Practices Act but in line with legislation in many other countries, the BCCA prohibits the offering or making of so-called "facilitation" payments, as well as the use "of a natural or legal third party to hide or cover up the real interests or the identities of the beneficiaries of the acts performed." Sanctions for violations are not dependent on a finding or criminal or corrupt intent - rather, the BCCA provides that the "legal persons [subject to the Act] shall be held strictly liable, administratively or civilly, for the injurious acts stipulated [in the Act] performed in their interest or benefit, exclusive or not."
The fines imposed for violations of the Act are significant - up to 20% of the entity's gross billings from the fiscal year prior to the initiation of administrative proceedings or, if the prior fiscal year's revenue cannot be calculated, of 60 million reals (about $26 million).
Entities violating the Act are also liable to being dissolved or suspended, and are subject to forfeiture and debarment as well as the loss of public "incentives, subsidies, subventions, donations, or loans from public bodies or entities and public financial institutions or those controlled by the public authorities for a minimum period of [one] year and a maximum of [five] years."
India is now the only BRICS (Brazil, Russia, India, China and South Africa) country that has not enacted legislation to prohibit the bribery of public officials by entities operating within the country. South Africa was first, with a law enacted in 2004, China and Russia followed in 2011.
Tags: brazil
Regulatory Focus newsletters
All the biggest regulatory news and happenings.