A Periodic Benefit Risk Evaluation Report (PBRER) is an analysis of the safety, efficacy, and efficiency of a drug, once it is already in the market. The PBRER submission is intended to present a periodic, comprehensive, brief and critical evaluation of new or emerging information on the risks of the health product and the product's overall benefit-risk profile. The authorities like the Food and Drug Administration (FDA), and European Medicines Agency (EMA) hold great prominence in terms of compliance with the periodic safety reporting. In simple terms, PBRER means submitting safety information to Regulatory authorities periodically. But in practice the Regulatory requirements make the process much more complex.
Freyr offers high quality of the summary bridging report and addendums and spot if there is any new sign of the drug benefits. We help clients create PBRER (previously a Periodic Safety Update Report [PSUR]) and Drug Safety Update Report (DSUR) to support pharmacovigilance (PV) for the products and make sure that the information provided in Package Leaflets (PL) and the Summary of Product Characteristics (SMPC) is up to date.
Timelines for PBRER (Periodic Benefit Risk Evaluation Report)
A Market Authorization Holder (MAH) is required to make the PBRER submission:
- every 6 months for the first 2 years after the product is marketed
- once a year for the following 2 years
- Preparation and review of professional and high-quality Periodic Risk Evaluation Report (PBRER) / Periodic Safety Update Report (PSUR)
- Compliance driven data generation
- Unified risk-benefit examination for all cumulative data
- Ready to use template for PBRER submissions
- In-depth analysis of evolving information and evidence
- New significant safety, efficient and value-added information
- Risk-reduction activities
- Updating the risk or signal assessments
The PBRER retains most of the basic elements of the PSUR, and additionally it is expected to have more information on:
- Clinical trials and observational studies
- Signals that are new, ongoing, or closed
- Risk evaluation and effectiveness of risk minimization
- Benefit evaluation
- Benefit-risk study for approved symptoms
- Comprehensive document modules useful for other Regulatory submissions like risk management plan
Freyr SUBMIT is a complete eCTD software product for the creation, validation, publishing, viewing and reporting of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities.
Learn more about Freyr’s eCTD Submission Solution