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You will find in this section the recent latest new from the ICH.
The Steering Committee endorses the establishment of an S1 EWG
In April 2012, the Steering Committee approved the S1 Concept Paper and Business Plan proposing to develop new guidance on rodent carcinogenicity testing. The aim of this new topic is to introduce a more comprehensive and...
ICH Q11 reaches Step 4 of the ICH Process
The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 4 of the ICH Process on 1 May 2012 and now enters the Implementation phase (Step...
Additional E14 Q&As available on the ICH website
In April 2012, the ICH E14 Implementation Working Group (IWG) finalised under Step 4 of the ICH Process four additional Questions and Answers addressing Sex Differences, Incorporating New Technologies, Late Stage Monitoring and...
Updated MedDRA Guidance available for MedDRA version 15.0
The ICH M1 "Points to Consider" Working Group updated the "MedDRA Term Selection" and the “Data Retrieval and Presentation” documents.