New validation criteria for electronic submissions from Sept 1, 2011, says EMA
In a web site posting, the European Medicines Agency is informing pharmaceutical companies that a new version of the validation criteria for electronic applications for human medicines is coming into effect on September 1.
The EMA 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 member states.
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, it warns.
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