The use of the Common Repository for Human Centralised Procedure submissions is now mandatory for all National Competent Authorities. Submissions sent to EMA via eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities' representatives and alternates. Submissions for Centralised Procedure should be made via EMA eSubmission Gateway/Web Client only. Additional copies should [...]
The SC agreed on the key issues relating to the reform of ICH in terms of the Articles of Association, funding model and membership. An important part of the reform effort is establishing a formal organisation with a new approach to membership, governance and shared funding among ICH members.
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.