International – Regulators, industry tout new approach for benefits-risk assessments

Regulators and industry representatives said that a new international guideline for evaluating the benefit-risk profile of new and marketed drugs developed by the Council for International Organizations of Medical Sciences (CIOMS) is a major step forward in improving such assessments.

Beginning in 2019, CIOMS Working Group XII has met a dozen times to work on an update to the 1998 CIOMS IV document Benefit-Risk Balance for Marketed Drugs: Evaluation of Safety Signals. CIOMS XII released a draft report of the updated document for comment in June 2023.

The revision provides a more structured approach to conducting these assessments and a major change is the guideline calls for these assessments to be conducted throughout the product’s lifecycle. During a 6 February panel on Global Pharmacovigilance sponsored by the Drug Information Association, companies were also told to establish cross-functional teams to conduct these risk assessments…