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Regulatory Focus™ > News Articles > EMA Launches Full eCTD Submission Platform for Human Medicines Applications

EMA Launches Full eCTD Submission Platform for Human Medicines Applications

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.


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