Due to planned maintenance, the PSUR Repository will be available intermittently on Thursday 22 June 2023, between 17:00 and 20:00. For any further information, please contact EMA Service Desk.

The European Medicines Agency will be carrying out essential maintenance activities on the Gateway. Users may therefore find the Gateway unavailable during this time. Friday, 14th October from 20.00hrs (UK time) to Monday, 17th October, 6.00hrs (UK time) During this period, it will not be possible to send messages via the Agency's Gateway. Depending on [...]

An updated version of the eSubmission Gateway XML delivery file user interface is available starting with 20 June 2023, 18:00. This update introduces a change to the Human Domain only, adding new fields to flag Real World Data/Real World Evidence for selected types of submissions.

The Assembly of the International Council for Harmonisation (ICH) met in-person on 12 & 13 June 2023, in Vancouver, Canada in parallel of meetings of 14 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. 

Due to planned maintenance, the PSUR Repository will be available intermittently on Monday 19 June 2023, between 18:00 and 22:00. For any further information, please contact EMA Service Desk.

Due to planned maintenance, the eSubmission systems (including eAF and PLM Portal eAF) will not be available on Saturday 17 June 2023, between 8:00 and 16:00. For any further information, please contact EMA Service Desk.

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.