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) 

Applications for Marketing Authorisation QRD Assessment Reports Article 29 Referrals to CMDh PSUR Variations Renewals RMP MRP / RUP Applicant's response

Notification form