Fludeoxyglucose (18F) - Revised Core SmPC and PL (August 2012)

The ICH Steering Committee has agreed to open ICH technical working groups to active participation from experts from non-ICH member regions and countries of the ICH GCG.

An important landmark has been achieved with the addition of a general statement indicating interchangeability pertinent to Health Canada in all Q4B topic-specific annexes.

The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents.

A comprehensive report of the last meeting of the ICH Steering Committee and its Working Groups that was held in Tallinn on June 5-10 2010 is now available on the ICH website under the ICH meeting reports.

In September 2010, new ICH Step 4 Tripartite Harmonised Guidelines have been released for implementation...

Paediatric Regulation: Article 46  Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (April 2025) [Track version]

Working Group on Active Substance Master File Procedures Working Party on Variation Regulation Working Party on Pharmacovigilance Procedures Work Sharing CTS Working Group Joint CMDh/GCP Inspectors Working Party  Non-Prescription Medicinal Products Task Force

Worksharing project on paediatric data  List of active substances and agreed SmPC wordings - EU work sharing procedure in the assessment of paediatric data (April 2010)

Guidance on the Application of the Amended Variations Regulation from 1 January 2025 In order to view some of the documents on this website you need Acrobat Reader (click here to download)