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Periodic Safety Update Report

What is Periodic Safety Update Report?

Periodic Safety Update Reports (PSURs) are basically reports that offer an assessment of the benefit-risk equilibrium of a drug. PSURs must be submitted at definite times following a drug’s authorization, this is done by marketing-authorization holders. Considering the risks, benefits, pros and cons of a medicine, the PSURs abridges and summarizes the data, taking in account all the studies that have been done with the drug, both in its certified and in uncertified uses.

The organization utilizes the data in PSURs to conclude if there are fresh threats recognized for a drug or whether the stability of risks and benefits of a drug has changed. Only then it can be settled on if more investigations are needed to be carried out or even take remedial and corrective measures to secure the masses from the dangers indentified, like revising the information given for healthcare experts and patients.

Evaluation of PSURs

The organization dispatches the subsequent papers to all marketing-consent holders whose drugs are part of a single PSUR evaluation.

  • Introductory single review report by the Pharmacovigilance Risk Assessment Committee (PRAC)
  • Revised single review report by the PRAC
  • PRAC commendation
  • Committee for Medicinal Products for Human Use (CHMP) outlook (if pertinent).

Single evaluations of PSURs solely based on active matters and combinations of active matters for centrally sanctioned drugs started in July 2012. The organization conducts single evaluations of active matters controlled only in nationally sanctioned drugs. The organization extended this to active matters contained in both centrally and nationally authorized drugs in April 2013.