The ICH E6(R3) draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process in May 2023 and subsequently entered the consultation period.

Version 01.06 of the PSUR Repository will be made available for both MAHs and NCAs on 14th of May 2016. The new release provides change requests and defect fixes further enhancing the system in preparation for the mandatory use starting on 13th June 2016. While the new version is made available the system will not [...]

• Publication of eAF version 1.20: Please note that following a very high number of testing feedback for the new version of the eAF, we are revising the publication date and the related release plan to ensure that a user friendly robust form will be released. The new date will be communicated as soon as [...]

An error had been detected in the eCTD published validation criteria. The updated version with the correc md5 checksums is available here.

From 23 May 2016 it will be possible to use XML delivery files instead of the existing filenaming conventions for number submission types via eSubmission Gateway/Web Client. We would like to involve industry representatives in the upcoming User Acceptance Testing (UAT) which is planned to take place with human and veterinary industry representatives: o from [...]

MAHs are advised that due to system maintenance work the product refresh for the PSUR Repository will be stopped during the following planned dates, which are currently: 11th March to 18th March 2016 22nd March to 29th March 2016 As a consequence MAHs that make changes to data in Article 57 during these periods will [...]

Due to planned maintenance of the eSubmission systems on Friday 9 June 2023, between 18:00 and 21:00 no submissions will be processed, therefore avoid sending submissions during this maintenance window. For any further information, please contact Service Desk

Version 01.19.0.2 of the eAFs has been made available to fix technical issue related to the locking of the variation form and issues with the availability of the controlled terminologies in all forms. If you have already started to fill in version 1.19.0.1 of the variation form please import the user filled data to the [...]

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Veterinary submissions (removal of obsolete submission types: extension, var-type1b, var-type2 and vet-psur).

The ICH M7(R2) Guideline on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has reached Step 4 of the ICH Process in April 2023.