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 06 November 2015 | By Michael Mezher
The European Medicines Agency (EMA) today issued draft scientific guidance intended to help sponsors design post-authorization efficacy studies (PAES).
The guidance, which comes a year after a new regulation, known as the Commission Delegated Regulation (EU) No 357/2014, established circumstances in which EU regulators could require PAES for all medicines. In the past, PAES were typically only required for medicines approved conditionally or under exceptional circumstances.
In addition to its scientific guidance, EMA also released a new questions and answers guideline intended to answer regulatory and procedural questions related to PAES.
PAES are sometimes required to determine aspects of a medicine's benefits "that can only be or need to be explored" after a product is approved. The studies can help clarify a products benefits in clinical practice or in other real-world scenarios that would be difficult or unnecessary to demonstrate in clinical testing.
However, the Commission cautions that these studies "should not be used as a justification for the premature granting of a marketing authorization."
Under Commission Delegated Regulation (EU) No 357/2014, national regulatory authorities, EMA or the EC can require PAES:
EMA says it expects these studies will "translate into better labelling and better use of medicines by patients and prescribers in clinical practice."
EMA says in the draft guidance, Scientific guidance on post-authorisation efficacy studies, can be applied to both imposed and voluntary PAES.
The agency says sponsors should select a study methodology "based on the scientific uncertainty to be addressed," and should be "feasible, ethically acceptable and of a design known to return reliable and interpretable results."
The guidance goes into additional detail on the specific circumstances in which a PAES may be imposed, including when there are uncertainties related to specific patient sub-populations, surrogate endpoints used to support marketing authorization or changes in scientific knowledge that "bring into question the criteria used to establish the efficacy of a medicinal product."
While PAES studies can be randomized or non-randomized, EMA says "studies involving randomization may be … preferred," but acknowledges that in some situations non-randomized studies may be appropriate, "where measures are included to minimize limitations/biases."
The agency says non-randomized observational studies should be conducted only when "randomization is unethical or unfeasible, outcomes are infrequent or are far in the future, the generalisability of randomized trials is limited, outcomes are highly predictable, or effect sizes are very large."
EMA
Scientific guidance on post-authorisation efficacy studies
Post-Authorisation Efficacy Studies: Questions and Answers
Tags: Post-authorisation efficacy studies, PAES, Post-authorization efficacy studies
Regulatory Focus newsletters
All the biggest regulatory news and happenings.