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The ICH S9 Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals reached Step 4 of the ICH Process in April 2018 and now enters into the implementation period (Step 5).
The factsheet provides information on how organisations can access the Medical Dictionary for Regulatory Activities (MedDRA), as well as work by the ICH MedDRA Management Committee to ensure that MedDRA is accessible to all those that need it.
The factsheet provides information on the multilingual nature of the Medical Dictionary for Regulatory Activities (MedDRA), including how interoperability between all translations of MedDRA is achieved.
In November 2017, the ICH Assembly and Management Committee met in Geneva, Switzerland, for their biannual meeting.
The International Council for Harmonisation (ICH) met in Geneva, Switzerland on 11 to 16 November 2017.
The MedDRA Management Committee met in Geneva, Switzerland on 11-12 November 2017.
The MedDRA Management Committee met in Geneva, Switzerland on 11-12 November 2017. Ms. Sophie Sommerer (Health Canada, Canada) was appointed as Chair with the unanimous support of the Committee to serve until November 2018.
The International Council for Harmonisation (ICH) met in Geneva, Switzerland on 11 to 16 November 2017. Among other decisions, the ICH Assembly approved the Health Sciences Authority, Singapore (HSA), as a new Regulatory Member.