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 ICH E18 Guideline on Genomic Sampling and Management of Data reaches Step 2b of the ICH Process in December 2015 and now enters the consultation period (Step 3). This new guideline is proposed to provide guidance on genomic sample collection to evaluate efficacy and safety of a drug for regulatory approval.
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).
The Membership and Observership Application Process is now available on the ICH website.
The PSUR Repository bulletin has been updated
As part of increasing the international outreach and inclusiveness of ICH, one of the first points of business was to review the application process for new Members and Observers. More information about the procedure, including application forms, will be published on the ICH website.
List of documents published on CMDh website (July 2025)(to be used to locate documents on the CMDh website)