Transitioning to eCTD v4.0
The Premier Consulting Blog
APRIL 27, 2023
Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. Implementation Package v1.5
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