ICH Releases Updated MedDRA Guidance
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.
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ICH - Updated MedDRA Guidance available for MedDRA version 15.0