An Overview of the Periodic Safety Update （定期安全更新的概述）.pdf

An Oracle White Paper May 2012 An Overview of the Periodic Safety Update Report for Marketed Drugs E2C (R2) Overview GVP Module VII: PSURs Executive Overview 3 History of the PSUR 3 Summary of GVP Module VII 4 Regulatory Action to Safeguard Public Health 5 Overall Content 6 Preparation of PSURs 7 Sections 7 Reference Information 11 Quality System 12 Transition and interim arrangements 13 ICH E2C(R2) PBRER Guideline 14 Changes to Summary Tabulations 17 Conclusion 21 Overview GVP Module VII: PSURs Executive Overview Good Pharmacovigilance Module VII – Periodic Safety Update Report is one part of the New European Pharmacovigilance legislation. Module VII provides guidance for the preparation, submission and assessment of PSURs. The new scope, objectives, format and content of the PSUR are described and are in accordance with ICH E2C(R2) guideline. What follows is a step-by-step analysis of the evolution of the PSUR, the content of Module VII and the E2C(R2) guideline and the anticipated impact to business. History of the PSUR 1992 CIOMS II Guideline on PSURs published 1996 Step 4 – ICH E2C Guideline published – Clinical Safety Data Management - Periodic Safety Update Reports for Marketed Drugs 2003 Step 4 - Addendum to ICH E2C (R1) published From 1996 thru 2010 PSURs adopted in 3 ICH regions and other ICH countries PSURs based on the CIOMS II Guideline of 1992 became widely accepted in all the ICH regions. Changes to the PSUR began to come about in March 2010 when a Draft ICH Concept Paper for the Review of ICH E2C was produced.