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.
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.
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