EMA to Apply New Electronic Submission Validation Criteria

Sep 01, 2011

EMA announced in a press release that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011. The new criteria (version 3.1) have been agreed with the regulatory authorities in European Union member states and will be applied to all electronic common technical document (eCTD) sequences received starting September 1.

“The Agency advises applicants to [familiarize] themselves with the new criteria. Applications that do not adhere to the new requirements will lead to a negative technical validation,” states the EMA press release.

The telematics implementation group for electronic submission (TIGes) met between September 2010 and January 2011, with the objective of revising the document. The TIGes harmonization group considered a number of change requests relating to issues that had arisen from the use of the current validation criteria (version 2.1), as well as additional feedback received.

Several high-level changes were made as a result. “Changes to priority” was one such change; in the previous eCTD criteria, the priority scale ranged from A to C. Although “A” was well understood to be a rejection based on technical grounds, the distinction between “B” and “C” was cause for confusion. A pass or fail categorization and so-called Best Practice will replace the old scale. Other high level changes included altered layout and presentation of the document, changes to file and folder naming, and increased alignment between eCTD and non-eCTD electronic submissions (NeeS) criteria. Harmonization between eCTD and NeeS was a common theme.

More specific issues arising from incorrect PDF versions, PDF security, and broken hyperlinks were also addressed.

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