eCTD publishing

CTD (Common Technical Document) describes the organisation of the regulatory documents supporting the authorisation of medicinal products.

The eCTD (electronic CTD) is a harmonised technical solution to implementing the CTD electronically. It consists of PDF documents, arranged in a set structure with defined folder and document names. eCTD is to be used when submitting documentation to authorities.

eCTD requires a dedicated software that creates separate Table of Contents with hyperlinks to the included documents, XML backbones and hyperlinks between documents.

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