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 email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 23 May 2013 | By Alexander Gaffney, RAC,
The European Medicines Agency (EMA) has announced that its eSubmission Gateway will become mandatory for all electronic common technical document (eCTD) submissions made to the agency through the centralised procedure starting in May 2014.
The eCTD is a standardized document format used around the world for the submission of pharmaceutical products, and uses a module approach to organize data in a way that makes submissions acceptable to a wide range of regulators. In recent years, several regulators, including the US Food and Drug Administration (FDA), have announced their intent to move toward a fully electronic submission system and away from one that permits submission through physical media such as CDs, DVDs and paper.
EMA has recently been experimenting with new electronic application systems, including one launched in March 2012 that allows marketing authorization applications (MAAs) to be submitted via an electronic application.
At the time, EMA said the launch of that program, still in the pilot phase at the time, was "a key step forward in the Agency's drive towards the use of electronic applications as standard, using the Electronic Common Technical Document (eCTD) format."
"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," it added.
That pilot program ended in July 2012, but in January 2013 EMA announced the launch of a submission format capable of being used by all members of industry, known as the eSubmission Gateway. At the time, EMA said it would still allow the submission of physical formats, but added that it was "only for the time being."
Now, that "time" is beginning to draw to an end. EMA's 23 May 2013 announcement indicated that all physical data formats will be refused as of 1 March 2014 for applications submitted through the centralized procedure.
Regulators said the new system would benefit industry by offering "an easier and quicker way to send eCTD submissions securely over the Internet," giving regulators the opportunity to send feedback and updates more quickly.
EMA added that applicants are invited to start using the system as soon as they wish, and that pediatric and veterinary drug submissions will be added to the capabilities of the system in the "near future."
EMA: eSubmission Gateway Announcement
Tags: eSubmission, Centralized Procedure, Centralised Procedure, MAA, Latest News, eCTD
Regulatory Focus newsletters
All the biggest regulatory news and happenings.