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 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.
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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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 Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 14 July 2017 | By Michael Mezher
The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.
"The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes.
Specifically, the updates include a new pre-submission checklist for type II variations and updated questions and answers guides for post-authorisation safety studies and classifying quality changes to marketing authorisations.
In the type II variation pre-submission checklist, EMA lists more than 100 items sponsors should have checked off before submitting a type II variation application to ensure the submission is complete.
The document also lists elements that could prevent the start of the procedure in bold and italic text. EMA notes the elements that are not emphasized can help with validation or assessment, but can be communicated during validation and will not delay the procedure.
For post-authorization safety studies, EMA has added 15 new questions and answers "to provide marketing authorisation holders with detailed information on the submission requirements, assessment and implementation of outcomes for protocols, protocol amendments and final study reports of non-interventional impost [post-authorisation safety studies]."
EMA also has added eight new questions and answers to help sponsors determine how quality-related changes to a marketing authorisation should be classified, such as the introduction of a new manufacturing site, or submitting information about a new working cell bank or reference standard for a biological medicine.
EMA
Tags: Post-authorisation, Post-authorisation safety studies, Quality, Type II Variation
Regulatory Focus newsletters
All the biggest regulatory news and happenings.