EMA: New Validation Criteria for Electronic Submissions into Effect Next Month
According to EMA's note, new version of the validation criteria for electronic applications for human medicines will come into effect on 1 September.
The European Medicines Agency has announced that a new version of the validation criteria for electronic applications for human medicines will come into effect on 1 September.
The Agency will be applying new electronic common technical document (eCTD) validation criteria (version 3.1) upon technical validation of all eCTD sequences received from this date. The Agency has agreed the new criteria with regulatory authorities in European Union (EU) Member States.
The Agency will release updated eCTD guidance for industry by the end of August.
The Agency advises pharmaceutical companies to familiarise themselves with the new criteria. Applications that do not adhere to the new requirements
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