All EMA IT systems temporarily unavailable from 06:00 on Saturday 16 April to 06:00 on Sunday 17 April 2016 (UK time) due to essential maintenance. The Annex 1 - A guide to the filenaming convention for eSubmission document describing the detailed filenaming conventions for submissions via eSubmission Gateway has been updated with new, additional filenaming [...]

In April 2016, further to the update of the Regulatory Notice Document (RND) in January 2016, the S1 Expert Working Group has completed a Prospective Evaluation Period Status Report.

The Q3D Training Modules 0-7 (Module 0: Overview; Modules 1-7 on key safety and quality topics) can now be found on the ICH website.

Version 1.20 of the eAFs will become available on 15 April 2016. To support the release of this next version of the forms: New versions of the eAF Data Exchange Standards (DES) and schemas have been released and can be found here. We are organising User Acceptance Testing (UAT) of version 1.20 of the eAFs. [...]

The EMA is extending the use of XML delivery files for all submissions excluding the Veterinary PSURs and Maximum Residue Limit (MRL) from 23 May 2016. A Statement of Intent on the extended use of XML delivery files for all submissions via the eSubmission Gateway/Web Client is now availa

The eSubmission Change Management Board and the Human Harmonisation Maintenance Group (HHMG) have adopted the updated eCTD validation criteria. The eCTD criteria have been updated in line with published EU Module 1 v3.0 following public consultation. The NeeS validation criteria have been updated to align to the updated eCTD validation criteria. The eCTD validation criteria [...]

On 6 April 2016, the Drug Information Association (DIA) in collaboration with the European Commission (EC) and the European Medicines Agency (EMA) are organising an “Information Day on ICH”.

ICH is pleased to welcome the Therapeutic Goods Administration (TGA) of Australia as its newest Observer.

Compliance statement for the agreed completed PIP   Recommendation for implementation of compliance statement for the agreed completed PIP (December 2015, correction May 2024) [Track version] Template on compliance statement for the agreed completed PIP (December 2015)

The revised version of the ICH E14 Questions & Answers on The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drug reached Step 4 of the ICH Process in December 2015 and now enters the implementation period (Step 5).