Rationale

CIOMS IV can be regarded as a logical progression from both CIOMS II and III. The aim of the working group was to develop guidance for regulators and manufacturers on assessing the balance between benefits and risks of marketed products with a newly established or suspected major safety problem. It would also provide guidance for deciding what options for action should be considered and on the decision-making process should such action be required. Pragmatic approaches to re-assessing the benefit-risk relationship, producing a standard report and good decision-making practices are highly desirable, but no standard existed. Although most signals will not warrant formal benefit-risk evaluation, it was recognised that any concepts proposed by the working group would be useful in any periodic or special evaluation of relative benefits and risks.

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