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Regulatory News: EMA’s New Validation Criteria for Electronic Submissions

26th October 2011

On 1st September 2011 The European Medicines Agency (EMA) implemented a new version of the validation criteria for electronic submissions for human medicines. 

The new electronic common technical document (eCTD) validation criteria (version 3.1) has been agreed with the regulatory authorities in European Union (EU) Member States and is now being applied to all electronic common technical document (eCTD) sequences received.
The EMA advises applicants to familiarise themselves with the new criteria.  Applications that do not adhere to the new requirements will receive a negative technical validation.

The EU Telematics Implementation Group for electronic submission (TIGes) met between September 2010 and January 2011, with the objective of revising the current eCTD validation criteria (version 2.1).  During this time the TIGes Harmonisation Group also considered feedback including a number of change requests from competent authorities.

As a result of the meetings a number of high-level were changes.  A Pass/Fail categorisation and so-called Best Practice now replaces the old criteria which used a priority scale from A to C to categorise the severity of the issue.  Although ‘A’ was well understood to be a rejection based on technical grounds the differences between ’B’ and ‘C’ had caused confusion. 

Other high level changes included:

• increased alignment between eCTD and non-eCTD electronic submissions (NeeS) criteria
• altered layout and presentation of the document
• changes to file and folder naming. 
More specific issues arising from broken hyperlinks, incorrect PDF versions and PDF security have also been addressed.

Full release notes and implementation information are available on the TIGes documentation page and updated eCTD guidance for industry will be published shortly.

Reviewed by:  Claire Pomeroy, Senior Regulatory Executive