Other Regulators Opinions (ORO) and Abbreviated (ABB) decisions

1.200          To inform the FSA Scientific Advisory Committees (SACs) and Joint Expert Groups (JEGs) that support the regulated products service, a ways-of-working paper (as TOX-2024-10 for COT) was presented to Members. This explained two additional ways in which the FSA would be assessing regulated products. These updated ways of working were 1) the use of other regulator’s opinions (ORO) by the FSA and 2) the use of an ‘abbreviated process’ (ABB) for safety assessments. These processes involve internal assurance via an FSA decision panel that is chaired by a senior leader from the Risk Assessment Unit with regular oversight from the FSA Chief Scientific Advisor. Applications progressing through these assessment routes would not routinely be considered by SACs, but a summary of the applications would be periodically presented to the COT for information.