All International Conference on Harmonisation (ICH) articles
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Industry newsICH 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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JournalAddressing the challenges of implementing the common technical document in Brazil
The common technical document (CTD) is the standard format for regulatory dossiers. It was developed in early 2000 for use in Europe, the United States (US) and Japan, and is currently accepted in several other regions such as Australia, Canada, India, South Africa, Switzerland and, since August 2019, Brazil, with the publication of Guide N°24/2019 from the Brazilian Health Regulatory Agency (Anvisa).