What Is a Periodic
Safety Update Report?

PSUR, or the periodic safety update report, is a pharmacovigilance report or medical device post-market surveillance activity with the objective to update regulatory authorities on the safety experience of a medical product after authorization.

The report is delivered by the medical device or pharmaceutical manufacturer as a requirement once the product is released into the market. The PSUR provides an update on the global safety of the product. It also includes a compilation of every adverse event reported during the reporting period and a thorough assessment of the product’s risk/benefit balance.

This assessment determines if further investigations are needed or if any changes to the product are required. Essentially, PSURs are reports summarizing the important conclusions taken from post-market surveillance activities of medical devices.

PSUR Explained

A PSUR evaluates the risk/benefit balance by considering all available information on a medical product. Using the post-market surveillance report, it’s determined if further studies or changes are needed.

The PSUR may include any of the following information:

• Preclinical research
• Unsolicited reports
• Non-clinical studies or spontaneous reports
• Ongoing monitoring systems
• Investigation of product quality
• Product usage statistics and usage patterns
• Clinical studies
• Real-world studies
• Patient assistance programs
• Comprehensive analyses and meta-analyses
• Scientific literature which has already been published or abstract reports

Who Submits PSURs?

In 2010, the EU created a rule that lets one assessment be used for a substance approved in multiple member states. The European Medicines Agency keeps a list of when PSURs must be submitted for substances used in the EU and regularly updates it.

PSUR submission is mandatory for marketing authorization holders (MAHs) as per data lock points in the EURD, or European Reference Date list, unless a product is eligible for routine PSUR reporting exemptions.

How Often Does PSUR Need to Be Submitted?

A PSUR must be submitted once in six months post-authorization until the product is marketed. The PSUR submitted for the launch period is regarded as the last submission before the product is put on the market.

For pharmaceutical products, PSURs must be submitted at specific intervals after the product is first put on the market:

• First two years: six-month submissions
• Next two years: annual submissions
• Subsequent years: every three years

For medical devices, a PSUR must be released every 2 years (for Class IIa devices) or every year (for Class IIb and Class III devices) after releasing the product into the market.

MAHs can request to shift their submissions via direct request.

Every PSUR must mention the duration since the previous submission, and it must be sent within sixty days of the data lock point (DLP). There should be no room for data overlaps or gaps. In case of uncertainty about data lock points or exceptional circumstances for a data lock point alteration, the manufacturer should speak with the governing body about PSUR requirements.