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 1.3.

eCTD in the Centralised Procedure

The EMA has announced plans to accept electronic-only submissions and eCTD only submissions over the coming 18 months. The strategy announcement can be viewed here, and a Question and Answer document relating to the strategy can be found here. A Question and Answer document relating to practical and technical issues is available here.

eCTD in the Mutual Recognition Procedure/Decentralised Procedure

Further to experience gained both by Industry and National Competent Authorities, the CMD(h) has developed guidance to facilitate the use of eCTD as submission format in the MRP and DCP. It is highly recommended and the aim of this is Best Practice Guidance (BPG) to encourage the submission of eCTD applications in the MRP and DCP and, therefore, to enable all parties to gain more experience. Any comments should be sent to the CMD(h) Secretariat (sonia.ribeiro@emea.europa.eu) until the end of 2008, coordinated where possible by trade associations.To access the BPG, please click here.

Documentation

Practical guidance for the paper submission of regulatory information in support of a marketing authorisation application when using the Electronic Common Technical Document (“eCTD”) as the source submission (v2.0)