The ICH Steering Committee has appointed Dr. Dawn Ronan as the new Director of the ICH Secretariat.

The ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients reached Step 4 of the ICH Process in June 2015 and now enters the implementation period (Step 5).

To facilitate the implementation of ICH Guidelines and other documents, the ICH website gets updated regularly with new training material.

Deletion of interaction between broad spectrum antibiotics and combined oral contraceptives (COC) Public Assessment Report (March 2015) corrected in March 2016 [Tracked]List of ATC codes for which the change applies (January 2016)

Implementation Working Groups (IWGs) have been set up for the ICH topics S3A, S9 and Q11 with a mandate to develop Question and Answer (Q&A) documents to clarify specific aspects of these Guidelines.

On 13 April 2015, 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”.

The ICH M8 electronic Common Technical Document Implementation Guide (eCTD IG) reached Step 2b of the ICH Process in February 2015 and now enters the consultation period (Step 3).

To facilitate the implementation of ICH Guidelines and other documents, the ICH website gets updated regularly with new training material.

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.