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.
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 01 June 2016 | By Michael Mezher
The European Medicines Agency (EMA) on Wednesday released its first statistics for its PRIority MEdicines (PRIME) scheme, naming the first four products to become eligible for the program, which seeks to speed the development of promising new drugs and biologics.
This is the first time EMA has released data signaling industry interest in PRIME since its launch in March. In total, EMA says it received 18 applications, mostly from small- and medium-sized companies, representing a range of therapeutic areas, including infectious disease, oncology, immunology and neurology.
Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated assessment of the product.
At its launch, EMA Executive Director Guido Rasi said the program was needed because, too often, drugmakers' development plans are inadequate or fail to generate the data EMA is looking for. Rasi added, "This is especially true for those developers that have less regulatory experience."
The newly released statistics detail EMA's decisions on applications to the PRIME program during its first month in operation.
In total, EMA says it received 11 of the 18 applications from small- and medium-sized companies. However, EMA says it only granted PRIME eligibility to four of the 18 applications:
The vast majority of applications to PRIME relied on both nonclinical and clinical exploratory data to demonstrate eligibility and their promise to meet an unmet medical need.
Only three applications relied on other combinations of evidence, none of which were granted PRIME eligibility. Of those products, one included clinical confirmatory data alongside nonclinical and clinical exploratory data; one relied on nonclinical data and a first-in-human tolerability study; and one relied only on nonclinical and "other" evidence.
EMA Press Release, Eligibility Decisions
Tags: PRIME, PRIority MEdicines Scheme, Biogen, Kite, Novimmune
Regulatory Focus newsletters
All the biggest regulatory news and happenings.