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Getting to Grips with the New Format for PSURs

On the 5th June 2013, Red Line’s Managing Director & QPPV attended the new 3 day course run collaboratively by the University of Hertfordshire and PIPA held at the Fielder Centre in Hatfield. Having gone through the painful process of transitioning to the new PV legislation, the team suspected the MD was really just looking for an excuse to get a few days away from the office.

The new changes in pharmacovigilance legislation has changed the face of drug safety and left many companies reeling in its wake. Having implemented the legislation in principle, companies are now getting to grips with the finer facets and nuances these changes present. Still, there are many grey areas about how to approach the new laws, not least of which is how to tackle the new format for the PBRER….Or is it the PSUR? 

So, at this point its worth pointing out that the old PSUR has taken on a new identity. Renamed the ‘Periodic Benefit Risk Evaluation Report’ or the ‘PBRER’, (pronounced pee-brer) it comes hand in hand with a new format as well. However, as we all know, nobody likes change so companies are still referring to the new PBRER as the PSUR. 

In April 2013, the FDA announced it would accept the ‘new’ EU PSUR format; however companies will need to submit a waiver first to enable them to replace the US PADER/PAER and submit the new EU PBRER/PSUR in its place. It’s rumoured that other major players, such as Japan, Australia & New Zealand, are likely to follow the US, in the not too distant future.

Regulator’s assessment reports of the new PSURs are providing constructive feedback and procedures need to be in place to take steps to resolve any deficiencies identified by the assessor, thereby enabling companies to improve the quality of subsequent submissions. 

Six monthly reporting is required in the EU for new marketing authorisations up to product launch and for the first 2 years of market exposure. At which point the submission frequency reduces to annually for the next 2 years and 3 yearly thereafter. The US still require quarterly reporting for the first 3 years post approval and annually thereafter. While Japan requires 6 monthly reporting for the first 2 years post approval, which also switches to annual reporting.

The EU reporting timelines provide 70 calendar days for submission of PSURs covering periods of up to 1 year, and 90 calendar days for submission of all other PSURs. The rest of the world, however, is still using the 60 day timeline for submissions which may need to be factored into your global schedule. 

In conclusion, the new PSUR format is a huge shift towards ongoing risk-benefit evaluation, requiring a collaborative approach between various departments. Key note speakers explained how workload for PSUR teams had risen and the new format required considerably more time to complete, in some instances time to completion had doubled.

Whilst the MD assures us, it was a great course, she has returned with even more vigour and a whole lot more work for the team.

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