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Guideline on Benefit-Risk Assessment of Health Products and Technologies

The benefit-risk assessment of medicines is a critical process in making regulatory decisions throughout their lifecycle as the product’s benefits and risks often change over time as new safety and efficacy information about the product becomes available.

Scope

Benefit-Risk Assessment (BRA) applies to:

• New Chemical Entities (NCEs):Evaluation during the marketing authorization process.
• Marketed Drugs:Reassessment when new safety signals, adverse events, or indications arise.
• Clinical Trials:Application at all stages to ensure ethical and safety considerations.

Triggers for the Conduct of a Benefit-Risk Assessment

• Safety concern or a change in the existing safety information of a health product or technology;
• The product’s efficacy (or, in the post-market context, its real-world effectiveness);
• A marketing application for a new indication;
• Public Health Concern.

Structural Requirements for the Conduct of a Benefits Risk Assessment

There are three main structural requirements for the conduct of a BRA, namely:

• Selection of a structured benefit-risk framework
• Sufficient and knowledgeable human resource
• Standard Operating Procedure (SOP) for benefit-risk assessment.

Target Audience/Stakeholders in BRA

• NRA is responsible for reviewing submissions;
• MAHs are responsible for developing and BRAs to the NRA
• Policymakers who use the findings to make decisions on change on

treatment guidelines

• Public and patients.

Regardless of the framework, the approach for the conduct of a BRA has five key steps, namely: planning, evidence gathering, data preparation, analysis, exploration, conclusion, and dissemination.

This guidance, therefore, provides a framework for the sponsors, drug developers, reviewers, marketing authorization holders, and researchers to systematically evaluate, report, and communicate the balance between the benefits and risks of a medicinal product in a standardized format. The evidence submitted in the premarket application and/or generated in the post-market setting informs PPB’s understanding of the benefits and risks of the drug.

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