Periodic Benefit-Risk Evaluation Reports (PBRER) and Periodic Safety Update Reports (PSUR). These are the Pharmacovigilance documents prepared and submitted for the assessment of the safety and risk of medicines post-marketing, but both these documents have a specific purpose and have distinct regulatory requirements. 

The following guidance documents are there for PBRER and PSUR these include 

• ICH E2C(R1) – Periodic safety update report guideline
• ICH E2C (R2) – Periodic benefit -Risk Evaluation Report 
• Guideline on good pharmacovigilance practices (GVP) module VII – Periodic safety update report Revision 1

Here we go with the key differences between PBRER and PSUR

Periodic Safety Update Report (PSUR)
1. Purpose: The primary area of a PSUR is the safety of a medicinal product. It aims to comprehensively summarize the drug’s safety profile over a specific period.
2. Content: It includes data on adverse events, cumulative safety information, a summary of significant safety issues, and the results of any new or ongoing safety studies.
3. Regulatory Requirement: PSURs are requirements of various regulatory authorities worldwide, including the European Medicines Agency (EMA). They are typically required for products that have been on the market for a longer period.
4. Back ground : The PSUR was the standard report before the introduction of PBRERs and is still used in some regions and for specific products.

Periodic Benefit-Risk Evaluation Report (PBRER)
1. Purpose: PBRERs provide a more comprehensive assessment, not only focusing on the safety but also evaluating the benefit-risk balance of the medicinal product. It aims to determine whether the benefits of the drug continue to outweigh the risks.
2. Content: In addition to safety data, PBRERs include information on the efficacy of the drug, new indications, data from clinical trials, and changes in the benefit-risk balance. It also considers the effectiveness of risk minimization activities.
3. Regulatory Requirement: PBRERs are required by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and are implemented in various regions, including the EU, Japan, and the US. They have largely replaced PSURs for products approved under these regulatory frameworks.
4. Integration: PBRERs integrate data from multiple sources to provide a holistic view of the drug’s safety and efficacy.

Key goals of PBRER IS 

•  To give comprehensive analysis of new and emerging information regarding the risks of medicinal products.
• Benefit risk profile
• to provide concise and required information to assure regulatory authorities that MAH is monitoring, evaluating risk profile of medicinal products.