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 24 January 2018 | By Michael Mezher
EMA says the goal of the survey is to identify companies that will require the most effort to make the necessary adjustments and transitions ahead of Brexit and to assist it and the European Commission in allocating resources to handle the additional workload.
The survey could provide a way to spur companies that have not begun preparations for Brexit to do so promptly.
According to EMA, more than a third (427/1165) of centrally authorized products on the EU market are made by UK-based drugmakers, and more than a quarter of centrally authorized products have a qualified person for pharmacovigilance (QPPV) based in the UK. EMA also says that 18% of the small and medium-sized enterprises registered with the agency are based in the UK.
In a separate notice, the European Commission writes that it and EMA "expect marketing authorization holders to prepare and proactively screen authorizations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time, considering the procedural timelines foreseen in the regulatory framework."
Last year, both EMA and the European Commission issued guidance on the steps UK-based drugmakers, and those with certain operations in the UK, will need to take to ensure their products can remain on the EU market after Brexit.
Specifically, UK-based drugmakers must transfer their marketing authorizations to entities established in the EU or European Economic Area (EEA) in order to continue marketing those products after Brexit. Sponsors of drugs with orphan designations will also need to transfer those designations to holders in the EU or EEA to maintain them.
EU regulations also require that drugmakers' qualified person for pharmacovigilance (QPPV) reside in the EEA and that their pharmacovigilance system master file be located in the EEA. Additionally, companies with quality control, batch release or import manufacturing sites located in the UK will need to make preparations to remain in compliance with EU regulations following Brexit.
EMA has already begun sending the survey out to UK-based drugmakers and drugmakers the agency has identified as having parts of their operations in the UK. Recipients will have until 9 February 2018 to complete the survey.
EMA, European Commission
Regulatory Focus newsletters
All the biggest regulatory news and happenings.