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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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.
Posted 27 February 2015 | By Alexander Gaffney, RAC,
The US Department of Health and Human Services (DHHS) has declared that a strain of enterovirus now sweeping across the US has a high potential to cause a "public health emergency," thereby allowing the US Food and Drug Administration (FDA) to clear the use of drugs and diagnostic devices under special "emergency use" regulatory pathways.
According to the US Centers for Disease Control and Prevention (CDC), the virus, known as enterovirus D68, is one of more than 100 non-polio enteroviruses. The virus disproportionately affects infants, children and teenagers, and can cause severe respiratory illness.
While the virus has been present in the US since at least 1987, a 2014 outbreak of the virus "was much greater than [outbreaks] reported in previous years," explained CDC on its website.
Unlike in past years, however, US healthcare officials have a new suite of regulatory tools they can use to confront the outbreak.
In March 2013, FDA was given a host of new authorities and responsibilities under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), a piece of legislation meant to bolster the government's ability to respond to health crises, and especially those of a biological nature.
Among the law's many provisions is one that allows FDA to temporarily approve a medical product if it determines that an emergency is likely to occur—a "threat justifying emergency authorized use," to quote the legislation. Previously, FDA was only permitted to approve products on an emergency basis if a public health emergency was already present.
The law also allows FDA to approve those products without first ensuring that they meet current good manufacturing practice (CGMP) regulations.
The bill was signed into law on 4 March 2013 by President Barack Obama, and received overwhelming bipartisan support during its passage through Congress.
Since then, DHHS has declared that several diseases pose "a significant potential to affect national security or the health and security of United States citizens living abroad." For example, DHHS has declared that the H7N9 influenza virus, the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), and the Ebola virus all represent threats to the US.
DHHS's declarations aren't just symbolic. Once a threat is declared by DHHS, FDA is then legally permitted to fast-track the authorization of new medical products under its emergency use authorization (EUA) provisions.
For example, FDA has already authorized the use of eight diagnostic tests meant to make it easier to diagnose patients suspected to have the Ebola virus. The agency has also authorized the use of three diagnostics for the H7N9 influenza virus, and one diagnostic for MERS-CoV. A standing EUA also covers the use of doxycycline to treat anthrax after suspected exposure.
Now, FDA will be permitted to take similar measures to help confront Enterovirus D68.
An early candidate for authorization is likely to be a diagnostic test developed by CDC and already in use by the agency. CDC's test reportedly allows for the diagnosis of the test "within a few days of receiving specimens).
It will therefore be up to FDA to determine whether CDC's test—and other tests—are sufficiently accurate to warrant emergency use authorization. If granted EUA, each test would be exempt from normal premarket regulatory requirements, but would need to accompany each device with specific labeling indicating that the device has not yet been granted approval.
There are currently no antiviral medications approved for use to treat the virus, CDC says.
Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68
Tags: Emergency Use Authorization, EUA, Emergency use Declaration, DHHS, Enterovirus D68
Regulatory Focus newsletters
All the biggest regulatory news and happenings.