Guidance

Regional Status of eCTD Adoption

eCTD is now entrenched as the global standard for regulatory submissions. The world’s leading regulatory bodies have declared eCTD as the preferred format, and many have taken it a step further with an outright mandate. In the past year, a majority of regional authorities have updated guidance and validation criteria, making it critically important that you stay informed and up-to-date.

This table provides a current overview of eCTD status at health authorities around the world.

eCTD Status with Global Health Authorities

Guidance documents eCTD submissions