A new version of the Common Repository will be available in March 2018 extending the system to other EMA led EU procedures submissions. Common Repository will extend and/or add new Cabinets to include the following types of submissions related to Human procedures: Signal Detection, PASS 107 NAPs, Work share NAPs, Ancillary Products.

The use of the eSubmission Gateway and/or the Web Client become mandatory for all paediatric applications from 1 January 2018. To allow applicant to adapt to the new submission requirements, the EMA will allow a transition period until 15 March 2018. After this date, the European Medicines Agency (EMA) will no longer accept submissions by [...]

New versions of the 4 electronic Application Forms (eAF v. 1.22.0.1) and the related release notes are now available. This new version is a hotfix release v1.22.0.1 of the forms can be used as of today (16th February 2018). The version of the form should not be changed during an ongoing procedure.

In November 2017, the ICH Assembly and Management Committee met in Geneva, Switzerland, for their biannual meeting.

New versions of the 4 electronic Application Forms (eAF v. 1.22) and the related release notes are now available. This release includes integration with OMS for organisation data and RMS for reference data. OMS will provide standardised organisation and location data. (For information, eAF has been integrated with RMS since June 2017.) This new version, [...]

User Acceptance Testing for eAF v1.22 outcome.In total 247 comments were received. We have fixed 62 defects (remaining defects will be assessed and prioritised in future releases). All submitted change requests will be analysed and prioritised.

From 1 December 2017, the use of Common Repository for Referral submissions replaces the use of CESP and CD/DVD for sending the Referral submissions to the National Competent Authorities (NCAs). All human referral submissions sent to the EMA will be considered delivered to all NCAs representatives and alternates. Submissions for all referrals should only be [...]

The International Council for Harmonisation (ICH) met in Geneva, Switzerland on 11 to 16 November 2017.

The MedDRA Management Committee met in Geneva, Switzerland on 11-12 November 2017.

eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.3 and the related release notes are available. The updated eCTD validation criteria and related release notes are now available. The updated NeeS validation criteria and related release notes are now available. A draft release schedule for 2018 the electronic Application Form [...]