Metronidazole End of procedure:…
Metronidazole End of procedure: 05/10/2010 Date of publication: 05/01/2011
New ICH Guideline Set to Replace Current E2C(R1) Guideline
The ICH Steering Committee has approved the development of a new ICH E2C(R2) Guideline to replace the current ICH E2C(R1) Guideline “Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs”.
ICH Celebrates 20 Years with a Refreshed and Revitalised New Visual Identity
As part of its 20th Anniversary celebration, ICH is pleased to announce the launch of a new logo and a new look for the ICH website.
Core SmPC/PL – Fludeoxyglucose (18F) – Revised Core SmPC and PL (December 2010)
Fludeoxyglucose (18F) - Revised Core SmPC and PL (August 2012)
Further Opening to Non-ICH Regions
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.
Health Canada recognises all ICH Q4B pharmacopoeial texts
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.
Updated MedDRA Guidance available with the release of MedDRA version 13.1
The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents.
Follow in details the main decisions taken by the ICH governing body
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.
Newly released Guidelines
In September 2010, new ICH Step 4 Tripartite Harmonised Guidelines have been released for implementation...
Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (July 2010)
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]