The creation of the electronic submission process enabled the phasing out of paper-based processes, allowing for more automated and efficient submissions to regulatory bodies. The first version of eCTD 3.0 was finalized in 2003, and 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 in 2015–2016 and intend to improve robustness, flexibility, and long-term stability, and advance the lifecycle management process. After many years of collaboration with regulatory bodies and industry sponsors, eCTD version 4.0 is finally ready for implementation.