The Common Repository has been extended to include all human Referral submissions from 1st September 2017. The use of the Common Repository for human Referral submissions will become mandatory for all NCAs on 1st of December 2017. There should be no referral submissions directly to any NCAs from 1st of December 2017 as these will [...]
The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions is now mandatory since the 1st of June 2018. Please see further details in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for [...]
The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.
Version 1.23 of the electronic Application Forms (eAFs) will become available on 13 July 2018. The release v1.23 will provide further integration with OMS from SPOR (Organisational/address data) and NTA changes. User Acceptance Testing (UAT) is planned to support the release of this next version of the forms
National information on MAH transfers (May 2025)
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 [...]