06 February 2012

EMA: Open consultation for updated versions of the technical validation criteria

The new validation criteria that came into force 1 September 2011 has been successfully implemented. However, there are some issues that need to be taken care of to further clarify, and harmonize the interpretation, and use of the criteria. A new draft version is now available for a short open consultation before it will be discussed, and finally adopted by TIGes, planned for the end of February.

The new proposals are marked as green fields and there is also an extra column added where some comments have been included by the TIGes Harmonisation group to explain the introduced changes.

If you have any major concerns that need to be addressed, please send your comments to the Chair of the TIGes Harmonisation group, Karin Grondahl by 13th February close of business.

The new version is planned to be effective from 1 June 2012. If you consider this date to be inappropriate for implementation in time,please describe any problems foreseen.

To download the document and find more information click here

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