A comprehensive report of the last ICH meeting that was held in Lisbon, Portugal on 12-13 November 2014 is now available on the ICH website under the SC Reports page.

Due to essential maintenance to our database systems, the PSUR Repository will not be available on Sat 31 Jan 15 09:00-18:00. The eSubmission Gateway will continue to be available throughout this period so MAHs can send PSUR submissions.

In November 2014, the ICH E2B(R3) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers which intends to clarify specific issues identified since the ICH E2B(R3) Guideline was published in the ICH Regions.

PAR for refused marketing authorisation applications (January 2017)

The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2013 and now enters the implementation period (Step 5).

A dedicated webpage for PSUR Repository is now available here. News and announcements related to the system availability including all user guidance documents will be published on this page.

The SC agreed on the key issues relating to the reform of ICH in terms of governance, new membership and funding. ICH remains committed to enhanced communication, transparency and the openness of ICH to all relevant stakeholders.

The eAF term request process has been updated and the relevant documents can be found here

The filenaming conventions for Veterinary Submissions have been simplified. It is now easier to submit Veterinary submissions using the eSubmission Gateway and the Web Client. Updated Annex 2 can be found here

From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD. The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission [...]