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 16 January 2018 | By Michael Mezher
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reassured drugmakers that there will be no sudden changes to the country's regulatory framework when it leaves the EU in March 2019.
In December, the UK and European Council agreed to advance Brexit negotiations to a second phase , and adopted guidelines for the continued talks, noting the UK's preference for a limited transition period under EU rules and regulations. The UK and EU also issued a joint report one week prior to affirming that products placed on the market before the UK's withdrawal should be able to remain on the market in both jurisdictions without modification or re-labeling.
Last week, the Financial Times also reported that the UK hopes to continue to follow EU regulations for medicines in order to minimize disruption to the biopharmaceutical sector.
"As the UK enters the second phase of negotiations, its position on medicines regulation remains clear. The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety," MHRA said.
But, in response to industry concerns over a no-deal scenario with EMA, MHRA reassured industry there would not be an abrupt shift in regulatory requirements and that it would take a pragmatic approach to promulgating new regulations.
"The European Union (Withdrawal) Bill will convert the exiting EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework," MHRA said.
Both the Association of the British Pharmaceutical Industry (ABPI) and UK Bioindustry Association (BIA) reacted positively to MHRA's statement and welcomed the agency's reassurance that it would take a pragmatic approach to instituting new regulatory requirements if a deal with the EU is not reached.
"Planning for this scenario does, however, require further detail, and further highlights why a realistic implementation period needs to be urgently agreed," ABPI said, warning of "very real consequences" for patients and the public health if favorable terms are not reached.
In the meantime, MHRA reminds companies that the UK is still an EU member state and that the agency continues to bid for EMA work. MHRA also said it is working "to ensure business continuity where procedures are likely to run beyond" March 2019, when the UK will officially leave the EU.
MHRA
Tags: Brexit
Regulatory Focus newsletters
All the biggest regulatory news and happenings.