Regulatory Programme Research: Benefit-Risk

Benefit-Risk Assessment

The objective of this programme is to achieve an internationally accepted approach for the systematic, routine and standardised documentation of decision making in the benefit-risk assessment of medicines.

Benefit-risk assessment has emerged from the CIRS Project 2020 study amongst member companies as one the most central topics in the development and approval of medicines. CIRS has become a driver in the various regional and global initiatives to address the need for improved methodology for these assessments.  Work will continue on the development and refinement of a framework for benefit-risk assessment and to study its practical application in the regulatory environment.

Programme accomplishments

• Developed a methodology for building the framework for benefit-risk assessment of medicines
• Initiated a programme of work to determine the practical application of the framework within the review process of regulatory agencies
• Engaged a consortium of four agencies (Health Canada, Australian TGA, Swissmedic, and Singapore HSA) to evaluate the CIRS benefit-risk framework and pro forma
• Organised a Workshop for companies and agencies to determine their perspective on appropriate weighting and values of benefit-risk parameters