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 22 June 2018 | By Michael Mezher
The European Medicines Agency (EMA) on Friday gave an update on the current and future status of its ongoing collaboration with the US Food and Drug Administration (FDA).
The two agencies have a long history of cooperation in a number of areas, including offering parallel scientific advice to drugmakers, and have collaborated on good clinical practice (GCP) inspections, quality by design and simplifying administrative barriers to improve cross-agency communication.
Most recently, EMA and FDA signed a landmark agreement to mutually recognize good manufacturing practice (GMP) inspections between participating national competent authorities and FDA, which has now expanded to 14 EU member states.
The update comes after the agencies' annual bilateral meeting that took place in Brussels earlier this week.
"The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, discuss strategic priorities for the coming years and further strengthen the continuous close collaboration with specific action in the field of pharmaceuticals," EMA said.
During the meeting, EMA said that the two regulators discussed measures to improve the mutual recognition agreement for GMP inspections.
Efforts are currently underway to expand the agreement to all EU member states by 15 July 2019, and the two agencies said they plan to work more closely on a technical level going forward. The regulators also reiterated their intent to include inspections for veterinary medicines and plasma-derived products in the agreement by July 2019 and July 2022, respectively.
EMA and FDA also agreed to encourage parallel scientific review for advanced therapies, such as cell and gene therapies and tissue engineered products, to support a common approach to development and postmarket data collection.
Additionally, the two agencies discussed how to streamline the review and approval of generic drugs, focusing on complex generic drugs in the US and hybrid generics in the EU.
However, EMA noted that planned cooperative activities will need to take into account disruptions due to its preparations for Brexit and upcoming relocation to Amsterdam.
EMA
Regulatory Focus newsletters
All the biggest regulatory news and happenings.