A brief history of PSUR/PBRER
In November 1996, ICH endorsed the ICH E2C (R1) Periodic Safety Update Report Guideline that established the PSUR (Periodic Safety Update Report) as a harmonized format for marketing authorization holders (MAH) to periodically report the safety information of approved drugs and biological products and described the PSUR’s content and submission timelines. At that time, the focus of the PSUR was on relevant new safety information in the context of patient exposure to determine if changes were needed to the reference safety information (RSI) to optimize the continued safe use of the product.
The term PSUR was then updated to PBRER in November 2012 because of the revision of ICH E2C (R1) to ICH E2C (R2) with the recognition of the assessment of the risk of a medicinal product is more meaningful when evaluated in the context of its benefits. The PBRER would emphasize the cumulative knowledge regarding a medicinal product while focusing on new safety information during the reporting period. This report also covers the proposed action(s) to optimize the drug’s benefit-risk profile.
ICH E2C (R1)- PSUR revised to ICH E2C (R2)- PBRER – This guidance:
Replaces PSUR with PBRER for reporting the overall safety and integrated benefit-risk evaluation of the commercialized or approved drugs during the reporting interval.
Describes the recommended format, content, and timings of PBRER submissions.
It intends to promote a more flexible approach in selecting the most appropriate reference product information for the PBRER.
Provides a modular approach to use the standard sections of PBRER in drafting DSURs (ICH E2F) or safety specification of a risk management plan (ICH E2E).
Why is it necessary to submit PSUR or PBRER to health agencies?
When a new medicinal product is approved for any indication, its safety and efficacy are based on the data from the limited number of human subjects in controlled randomized trials. Sometimes, high-risk patients with life-threatening conditions or concomitant illnesses who take other drugs are excluded from the study. As a result, it is a very challenging task to monitor and evaluate the adequate safety of the medicinal product before commercialization. However, once the drug is on the market and exposed to diverse people with multiple health conditions, it becomes imperative to monitor the safety of the drug closely. Therefore, once the drug is approved for an indication, health agencies expect Marketing authorization holders (MAH) to submit PSUR/PBRER periodically to report any adverse effects of the medicinal product.
Critical differences between PSUR and PBRER
Submission frequency in India, the US, EU member states, and Japan
Glossary
