New Electronic Submission Validation Criteria

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.