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Benefit-Risk Assessment Framework Moves Toward Global Harmonization

 
• By Cathy Dombrowski

PhRMA shifts further development of its structured benefit-risk assessment framework to the European organization CIRS, which has relationships with regulators in Europe, the U.S. and elsewhere that can drive the framework’s adoption for the drug approval process.

The Pharmaceutical Research and Manufacturers of America is transferring its framework for risk-benefit assessment to the Centre for Innovation in Regulatory Science Ltd. for further development on the road to harmonization of how companies and regulators evaluate drugs.

The transfer, announced Jan. 30, helps consolidate efforts to bring consistency to benefit-risk assessments across the globe

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