Regulatory Focus™ > News Articles > ICH Releases Updated MedDRA Guidance

ICH Releases Updated MedDRA Guidance

Posted 03 April 2012 | By Alexander Gaffney, RAC 

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) released 2 April new guidance on using the Medical Dictionary for Regulatory Activities (MedDRA).

The two released guidance documents - MedDRA Term Selection: Points to Consider Documents and MedDRA Data Retrieval andPresentation: Points to Consider Documents - provide best practice approaches for data entry (coding) and data retrieval/analysis for MedDRA version release 15.0.

MedDRA Term Selection: Points to Consider Documents is to promote accurate and consistent term selection.

MedDRA Data Retrieval and Presentation: Points to Consider Documents is to demonstrate how data retrieval options impact the accuracy and consistency of data output, including how certain drugs of therapeutic areas may need a customized approach for data output.


Read more:

ICH - Updated MedDRA Guidance available for MedDRA version 15.0

ICH - MedDRA Points to Consider Documents


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