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A Periodic Safety Update Report (PSUR) is a pharmacovigilance document which provides information related to the risk-benefit balance of a drug product post its authorization. The purpose of a PSUR is to give an overall analysis of the risk-benefits of the product, considering all the information (including the latest information) about the drug product. Depending on this report, it will be decided whether the product requires further studies or if some changes are required. As per the Regulation (EU) No 1235/2010, Directive 2010/84/EU and Commission Implementing Regulation (EU) No 520/2012, it is mandatory for Marketing Authorization Holder (MAH) to submit the PSUR to the European Medicines Agency (EMA).

Format and Content of a PSUR

A PSUR should contain all the present available information of the product in addition to emerging information. The report must present all the relevant data of the risk and benefits associated with the product along with its impact on the market authorization. The following information can be a part of the PSUR:

  • Non-clinical studies
  • Spontaneous reports
  • Active surveillance systems
  • Product quality investigations
  • Product usage data along with information related to drug utilization
  • Clinical trials
  • Observational studies
  • Patient support programs
  • Systematic reviews and meta-analysis
  • MAH sponsored websites
  • Scientific literature which has already been published or reports compiled from abstracts
  • Manuscripts which have not been published before
  • Licensing partners, other sponsors or academic institutions and research networks
  • Competent authorities

Apart from the list mentioned above, additional information can be added by the MAH to demonstrate the safety, efficacy and effectiveness of the product. As of June 13, 2016, all the MAHs are required to submit the PSURs to the European Union central PSUR repository using the eSubmission Gateway/ Web Client.

Authoring a PSUR can be a daunting task if all the elements aren’t properly tracked. Therefore, it is suggested that MAHs should consult a Regulatory expert before proceeding to author and compile a PSUR. To know more about PSUR and other aggregate reports required by the EMA, reach out to Freyr at sales@freysolutions.com.