As per the structure of the eCTD, the product information should be provided in pdf format within Module 1.1.3. However it is occasionally necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate [...]
The ICH M8 EWG would like to assess the readiness of eCTD v4.0 Vendors and their development and/or readiness to deliver a production ready eCTD v4.0 solution. We request that the eCTD v4.0 Vendor Readiness Survey be completed by September 15, 2019.
A webinar providing an update of the CESSP phase 1 project (converting the current eAFs into web based forms) will be held on 7 May 2019 from 10:00 to 11:30 CET. This webinar is aimed for applicants (from pharmaceutical industry). A separate session aimed for regulators will be be organised in near future.Please note that [...]
The release notes for MAA Human and Veterinary electronic Application Forms (eAF) and the Renewal eAF have been updated to reflect new known issues
A minor update has been made to the Q and A on how to handle ongloing procedures in relation to mandatory eCTD format.
An Active Substance Master File (ASMF) can be used to replace the documentation for an active substance, required as part of an initial marketing authorisation application (MAA) or subsequent marketing authorisation variation (MAV). Appropriate guidance is given in the CHMP/CVMP guideline on active substance master file procedure. A specific ASMF can be used for multiple [...]
New versions of the 4 electronic Application Forms (eAF v. 1.23.1.0) and the related release notes are now available. This new version is a hotfix release v1.23.1.0 of the forms and can be used as of today, 28th September 2018. The current versions (v1.23.1.0) of the forms can be used and will fully replace the [...]
Please note that the EMAeSubmission Gateway web UI is being updated to reflect in the field “Submission format” the VNeeS version 2.6 for Pharmaceutical and Immunological products. For the time being, therefore, please submit your applications in VNeeS version2.6 using the submission format 2.5.
The following updated Annexes to the eSubmission Roadmap have been published to reflect further details on the practical implementation steps. Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions, Annex 4 to the HMA eSubmission Roadmap on the replacement of the current PDF electronic application forms [...]
The updated Annexes to the Roadmap are being published as they become available to reflect further details on the practical implementation steps. Annex 1 to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for Human [...]