The folks at GlobalSubmit have posted some great eCTD resources.
Many global agencies have mandated the eCTD as their preferred format. The site contains a good summary of eCTD status for major health authorities, including FDA, Health Canada, EMEA, and ASEAN.
Knowing the status of eCTD implementations is helpful for regulatory affairs staff but moving towards the eCTD requires a clear understanding of the processes and best practices to ensure success. Check out their best practices section for valuable "lessons learned" that could help smooth your path towards eCTD readiness and adoption.
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Categories: pharmaceuticals, regulatory, XML
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