An introduction to PSURs and PBRERs
Today I am introducing Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Evaluation Reports (PBRERs) for medicinal products.
Don’t miss the important tip for today at the end of this blog…
What is a PSUR/ PBRER?
A PSUR/ PBRER is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of the product. It provides an analysis of the safety, efficacy, and effectiveness of the product over its lifecycle. This evaluation takes place at defined time points after its authorisation. The assessment needs to be performed whether the product is placed on the market or not.
The ICH guideline describes the primary objective of the PSUR is to provide a comprehensive picture of the safety of approved medicinal products. With recognition that the assessment of the risk of a medicinal product is most meaningful when considered in light of its benefits, the PBRER provides greater emphasis on benefit than the PSUR, particularly when risk estimates change importantly. In such cases there will need to be an overall explicit evaluation of benefit-risk. Consequently the name of the proposed report is the “Periodic Benefit-Risk Evaluation Report” (PBRER). The PBRER would also provide greater emphasis on the cumulative knowledge regarding a medicinal product, while retaining a focus on new information. A formal evaluation of benefit is a new feature of the PBRER; however, it is recognised that a concise discussion of benefit will usually be sufficient, unless the safety or benefit-risk profile has changed significantly during the reporting interval.
Why do we need PSURs/ PBRERs?
PSURs/ PBRERs are needed due to the fact that the data from clinical trials tends to be over a short time frame and with small patient numbers in a controlled situation. Once on the market the product will be used by larger numbers of people and in patient groups for which data may not yet be available, such as:
- pregnant or breast feeding
- hepatic or renal impairment
Delayed onset Adverse Drug Reactions (ADRs) may also be experienced after product launch.
What is the objective of a PSUR/ PBRER?
The objective of a PSUR/ PBRER 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.
What kind of information should I include in my PSUR?
Most of the information to include will be related to safety, but you should include information on any new limitations of the medicine and alternative treatment areas as well.
The legal requirements for submission of PSURs are established in the Regulation (EC) No 726/2004 and the Directive 2001/83/EC.
“You must not wait for the PSUR submission to notify regulatory authorities of any significant new information relating to the safety and efficacy of your product.”
Other blogs in this series include: