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 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