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Appendix 17.1: Price transparency remedy Contents Page Parties responses to the Remedies Notice................................................................ 1 Summary of evidence regarding the
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How to fill out benefit-risk balance for marketed

01
Gather all relevant pre-clinical and clinical trial data.
02
Identify and list the benefits of the marketed product.
03
Identify and list the risks associated with the marketed product.
04
Quantify the benefits and risks where possible (use statistical data).
05
Consider the impact of the product on the target population.
06
Evaluate the benefit-risk balance by comparing the total benefits against the total risks.
07
Document your findings and rationale clearly.
08
Submit the benefit-risk balance assessment to the appropriate regulatory body if required.

Who needs benefit-risk balance for marketed?

01
Regulatory agencies for product approval and monitoring.
02
Healthcare professionals to inform treatment decisions.
03
Patients to understand the implications of treatment options.
04
Pharmaceutical companies for ongoing product assessment and marketing.
05
Researchers for further studies and investigations.
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The benefit-risk balance for marketed refers to the assessment of the therapeutic benefits of a marketed product compared to its potential risks, ensuring that the benefits outweigh the risks for the patients.
Pharmaceutical companies and manufacturers of marketed products are required to file the benefit-risk balance.
To fill out the benefit-risk balance, companies must collect data on the product's efficacy, adverse effects, patient population, and context of use, and clearly document this information in the provided regulatory format.
The purpose of the benefit-risk balance is to ensure that marketed products provide a meaningful therapeutic benefit to patients relative to their associated risks.
Information must include clinical efficacy data, safety information, demographics of patient populations affected, duration of treatment, and any mitigating factors for reported risks.
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