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Industry news
ICH releases M15 guideline on model-informed drug development
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation.
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Industry news
Stakeholder feedback sought on EMA draft clinical guidelines
The EMA has published draft guidance − ICH E6 (R3) − on good clinical practice for clinical trials, which is open for public consultation.