Drugmakers must adhere to the European Medicines Agency’s (EMA) new
validation criteria for electronic common technical document (eCTD)
submissions beginning 1 September. EMA has agreed to the new criteria
(version 3.1) with regulatory authorities in EU Member States, and has
advised sponsors to become familiar with it. Applications that do not
adhere to the new requirements will lead to a negative technical
validation, according to an EMA press release.
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