EU: Proposal of new validation criteria for eCTD and NeeS open consultation

The TIGes Harmonisation Group has released a proposal for new eCTD and NeeS validation criteria that are open for consultation. The release goes inline with the Notice of Intend from 16-Sep-2010 to review and update the EU NeeS and eCTD validation criteria.

The current release comprises:

1. A Message to be read in connection to the proposal of the new validation criteria for eCTD and NeeS
2. Proposal of new validation criteria for open consultation
3. A functional description of a eCTD / NeeS checker (algorithm mainly intended for vendors of validation tools)

The experience with creating and receiving NeeS and eCTD submissions to thoroughly review the criteria currently used and Change Requests that were received from stakeholders in the meantime were take into account in the preparation of the new proposals. The principles outlined in the Notice of Intent have been applied during the review.

The TIGes harmonisation group encourages all sponsors, applicants, CROs and software vendors to comment on the released proposal. Instructions and expectations on the review are included in the message from TIGes (see 1. above). Responses should be sent to eSubmission@mpa.se by 26 November 2010.

[Source: EMA/TIGes website]

Related News:

 New eCTD and NeeS validation criteria released by EU Telematics Implementation Group - 07.02.2011 18:45

 EU: TIGes releases Notice of Intent to update the European eCTD validation criteria - 16.09.2010 14:50

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