The ICH S9 Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals reached Step 4 of the ICH Process in April 2018 and now enters into the implementation period (Step 5).

Release Milestone plan for eAF has been updated. Note: The milestones for the planned mandatory use of OMS within the eAF and CESP Dataset Module are currently under review and will be published soon.

The guideline on eSubmissions for Veterinary products - version 2.6, related Validation checklist 2.6 and VNeeS Checker version 2.6 have now been published. They will enter into force on 1 September 2018 - see links under section “Future Guidance” on the vet esubmission webpage. The update of the guideline is related to alignment with the [...]

The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions will be mandatory from 1st June 2018. Until this time, a transition period is ongoing, whereby the use of the Common Repository is being implemented in a stepwise approach, as indicated in the Dossier requirements for submission of marketing authorisation [...]

Validation criterion 16.3 for eCTD submissions has been extended to exempt also m1.0 from some PDF checks as m1.0 is mentioned in criterion 16.4 specifically due to the PASS form. The updated eCTD validation criteria and related release notes are now available. Validation criterion 3.3 for NeeS submissions has been extended to exempt also m1.0 [...]

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, [...]