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. After many years of collaboration with regulatory bodies and industry sponsors since, eCTD version 4.0 is finally ready for implementation.
This paper provides insights into the numerous benefits of eCTD 4.0, including improved structure, a singular format adaptable to multiple agencies and regions, reduced structural changes, and enhanced metadata and keyword definition. Discover how advanced lifecycle management and document reuse can save you time and resources while empowering two-way communication with regulatory bodies.
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Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.
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