IDMP Wiki

PSUR

Periodic Safety Update Report (PSUR)

The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits.

1 September 2015, companies should use the xml delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client websites

The PSUR XML delivery file for EMA submission is introduced to harmonise the submission mechanism for all PSURs submitted to EMA and it will apply to all types of PSUR and PSUR supplementary information submissions.

PSUR Substances in the “Active Pharmaceutical Ingredients Dictionary”