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 26 August 2013 | By Alexander Gaffney, RAC,
In recent years, the electronic Common Technical Document (eCTD) has become the application type of choice for regulatory professionals operating in the US, EU, Japan and many other markets, offering them a relatively straightforward way to file small variations on a single application to multiple regulatory bodies. Now the US Food and Drug Administration (FDA) has announced the publication of final versions of several documents outlining specifications used in the eCTD's backbone files.
The eCTD is built on a machine-readable format known as extensible markup language, more commonly known as XML. This format allows a wide variety of programs to read the same data, but requires the XML to be formatted according to certain specifications.
FDA periodically updates its eCTD documents, typically to expand what information is allowed to be submitted under the XML schema. For example, an April 2013 update allowed the submission of limited media content in eCTD applications, while an earlier February 2013 update permitted limited information about related medical devices.
Now FDA is out with several new eCTD updates, including changes to three documents:
So what's new? Mostly minor or cosmetic changes, FDA explained in an accompanying Federal Register document. For example, headings for several sections have seen changes, which required changes to be made to the Contents Headings document.
In all, FDA said, most of the main changes had already been proposed in February 2013, part of a "major update" to Module 1 (i.e. the region-specific module) of the eCTD. The new changes, FDA added, are revisions to the February update.
Files submitted using the eCTD Module 1 specification (Version 2.2) will be accepted by FDA starting in June 2014, and the agency said it will give at least 30 days advance notice to industry before the changeover.
Federal Register Document
eCTD Important Notices
Tags: Module 1, XML, Latest News, eCTD, update
Regulatory Focus newsletters
All the biggest regulatory news and happenings.