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 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 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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 11 January 2012
A new report released by the US Customs and Border Protection (CBP) on 9 January shows a dramatic increase in the amount of counterfeit pharmaceutical products seized by CBP during fiscal year (FY) 2011.
Pharmaceutical products represented the third most popular category of commodities seized by CBP during FY 2011, representing 1,239 seizures worth $16.9 million, or 9% of all the value of all goods seized. This represents a three-fold increase over 2010, when CBP seized 433 product shipments worth $5.6 million, or 3% of the value of all products seized.
The Manufacturers Suggested Retail Price (MSRP) of all pharmaceutical products seized amounted to $24.8 million in FY 2011.
When ranked by category, pharmaceuticals represented 28% of the "consumer safety and critical technology" category. This represents a marked increase for pharmaceuticals over FY 2010 when pharmaceuticals represented just 13% of that same category.
"CBP and ICE [Immigrations and Customs Enforcement] conducted a number of successful enforcement efforts in FY 2011 targeting counterfeit pharmaceuticals," noted the report.
Certain countries were listed by the report as being the most notorious origins of counterfeit products. Pharmaceutical products were seized from China ($6.9 million), India ($3.9 million), Pakistan ($3.4 million) and Hong Kong ($1.7 million) during FY 2011.
The report noted that while the overall percentages of products seized from countries had remained relatively stable, the value of certain products originating from countries had increased. "The value of pharmaceutical seizures from China increased by more than $4.3 million" in FY 2011 according to CBP.
Pharmaceutical counterfeiting seizures vaulted India and Pakistan into CBP's "Top Ten Source Countries," accounting for "86% of the value of IPR [Intellectual Property Rights] seizures from India and 85% of the value of IPR seizures from Pakistan."
Tags: Smuggling, ICE, CBP, Counterfeiting, Customs, Latest News, pharmaceutical
Regulatory Focus newsletters
All the biggest regulatory news and happenings.