September 30, 2010
Updated MedDRA Guidance Available with the Release of MedDRA Version 13.1
The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents.
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The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents.
A comprehensive report of the last meeting of the ICH Steering Committee and its Working Groups that was held in Tallinn on June 5-10 2010 is now available on the ICH website under the ICH meeting reports.
In September 2010, new ICH Step 4 Tripartite Harmonised Guidelines have been released for implementation.
This document has been prepared at the occasion of ICH's 10th Anniversary in 2000 by the European Federation of Pharmaceutical Industries and Associations (EFPIA), JPMA and PhRMA.