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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
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.
Posted 15 January 2013 | By Alexander Gaffney, RAC,
The European Medicines Agency (EMA) has launched its eSubmission Gateway and a new eSubmission web client for the submission of applications for human medicines, it announced on 15 January 2013.
The eSubmission platform allows for the submission of the electronic common technical document, a harmonized, tiered submission format that allows for easier submissions across multiple geographic regions.
The release II update to the gateway "allows applicants to submit documents supporting all types of applications for human medicines to [EMA] securely over the internet in the eCTD format," EMA said in a statement. Previously, only certain applicants-typically larger, higher-volume applicants-were allowed to use the gateway.
"This is expected to simplify and speed up the application process by improving data quality and consistency, providing access to data in Extensible Markup Language (XML) format, and integrating application data with controlled vocabulary lists," EMA of the program back in May when it was released as a pilot program.
In a press release on 15 January, EMA officials said that the release of its new web-based submission client would be particularly useful for small and medium-sized enterprises (SMEs), and that registered applicants are already cleared to begin submitting applications using the tool.
Non-electronic submissions will still be accepted on CD/DVD-formatted disks, but EMA said that arrangement was "only for the time being."
"It is essential that applicants only use one method of submission as duplicate submissions might lead to negative technical validation and cause a delay in the processing of the application," EMA wrote.
The release follows the completion of a four-month pilot program launched in May 2012, intended to test out the eCTD as the standard for submissions and allow for the more rapid submission and review of applications and data.
The agency is also working on accepting electronic veterinary submissions, though it noted that those capabilities are not yet online, though it released guidance on that topic in 2012.
Tags: eSubmission Gateway, Electronic Submission, MAA, Latest News, eCTD, EU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.