Periodic Safety Update Reports

Periodic Safety Update Reports

INTRODUCTION

The periodic safety update report (PSUR) is a document that allows a periodic, comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The concept evolved from the Council for International Organizations of Medical Sciences (CIOMS) Working Group II report (CIOMS, 1992). The process that culminated in the publica-tion of that report was initiated in 1989, at a time when several countries had requirements for periodic safety updates. Individual local regulatory authori-ties were requesting that both foreign and domes-tic data be presented according to different inclusion criteria, formats and time intervals, and the number of reports that had to be produced was placing a high administrative burden on manufacturers. The purpose of CIOMS II was to explore the possibil-ity of developing a harmonised approach to prepar-ing PSURs that would meet most existing needs and forestall any diversity in future requirements. CIOMS II formed the basis for the International Conference on Harmonisation E2C Guidance for Industry (ICH, 1996), which defined the format and content for PSURs and introduced the concept of an international birth date (IBD) – the date of first approval in the world. ICH E2C set the period for review of inter-val (rather than cumulative) safety data as 6 months. After it was adopted, practical considerations regard-ing the content and preparation of the report were addressed in the CIOMS Working Group V report (CIOMS, 2001), and many of the recommendations in that report formed the basis of an addendum to ICH E2C (ICH, 2003). The addendum introduced to the PSUR new concepts that were not in E2C but that reflect current pharmacovigilance practices. These include confidentiality of proprietary information, risk management programmes and benefit–risk analyses. The PSUR has now been adopted in many European countries, Japan and the United States. It is emerging as a gold standard of safety evaluation for marketed drugs and an important pharmacovigilance tool.