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The eCTD (Electronic Common Technical Document)

The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use in each of the European Union, Japan and the United States (the three regions that are party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for human Use - "ICH"). The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.

Since June 2003, applicants have had the option of submitting an eCTD in parallel with the paper submission (CTD), following sign-off by the ICH Steering Committee of the eCTD Specification document at Step 4, and the adoption of this Specification document by the CPMP. In November 2003, the ICH M2 group revised the specification for the eCTD to version 3.2 , which remains the current version. In the context of the implementation of the eCTD in the European Union, the Electronic Submission Telematics Implementation Group (TIGes) has developed a specification for the regional module . The Specification has been published in the Notice to Applicants, and the current version is version 2.0.

eCTD in the Centralised Procedure

In centralised procedure the EMA now only accepts submissions received in eCTD format. We understand that there may be occasions when applicants are unable to comply with this electronic requirement and in those circumstances we will accept paper submissions.

Since January 2013 and "Mandatory from March 2014" all eCTD submissions must be sent using the dedicated submission channels: eSubmission Gateway or the related eSubmission Web Client

eCTD in the Mutual Recognition Procedure/Decentralised Procedure

To facilitate the use of eCTD as the highly recommended submission format in the MRP and DCP, a Best Practice Guide is published by the CMDh (see the link below). Any change requests to the document should be handled through the Change Control Process. The process and forms can be found here.

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