Periodic Safety Reports

Periodic Reporting is the preparation and submission of safety information(Adverse events, lack of efficacy, accidental exposure, medication error, withdrawal effects, product quality complaints, off-label use etc) about a medicinal product on a periodic or timely basis e.g every year or every 3 months or every 6 months.

These reports are also known as aggregate reports or cumulative reports since these reports present a compilation of safety data over a prolonged period of time as opposed to single case reporting which involves only individual AE reports (ICSRs). Periodic reports play an important role in risk-benefit evaluation of a drug and are required to be submitted to various regulatory agencies to comply with regulatory requirements. They provide a broader view of the safety profile of a drug.

Major types of Periodic Reports are:

DSUR — Development Safety Update Report

Its a periodic report for drugs under development(including marketed drugs that are under further study). It is submitted on annual basis. It replaces the current IND Annual Report (AR) in US and Annual Safety Report(ASR) in EU.

PSUR — Periodic Safety Update Report

PADER — Periodic Adverse Drug Experience Report