Including Understanding of Regional Differences and Benefits
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and other regulatory reports to health authorities around the world. eCTD v3.2 has been the default version for more than 10 years since its release in 2008. The initial draft implementation guidelines for eCTD 4.0 were developed between 2015 and 2016 to improve robustness, flexibility, long-term stability, and a more advanced lifecycle management process. After many years of collaboration with regulatory bodies and industry sponsors, eCTD version 4.0 is finally ready for implementation.
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