ICH E2C(R2) - Periodic Benefit-Risk Evaluation Report

What it says

E2C(R2) describes the format and content of the Periodic Benefit-Risk Evaluation Report, a periodic report that gives a comprehensive evaluation of the benefit-risk balance of an approved medicine. It covers marketing and exposure data, summaries of safety and efficacy findings, signal evaluation, and an integrated benefit-risk analysis with conclusions and proposed actions.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The report moves beyond listing adverse events to weigh benefits against risks over the reporting period.
• The same report can serve in several regions, though submission schedules vary by authority.
• Signals found in the period and the actions taken should be clearly described.

What inspectors look for

• Whether periodic reports are prepared and submitted on time.
• Whether signals and their evaluation are properly described.
• Whether data in the report match the safety database.

Related regulations