CRED Understanding Clinical Development 2024

09/10/2024

Differences in Expedited Reporting in USA and Japan

SUSARs

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• In USA to FDA and investigators (can remain blinded to both). Requires an analysis of similar reported events to be submitted with the expedited report

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In Japan to PMDA and Investigators

Expectedness

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• In USA and Japan no requirement for list of expected serious ADRs in the IB and mention of an AE somewhere in IB is often interpreted as meaning that an event is expected

Reaction

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• In USA can be determined only by the company causality assessment

• In Japan any causality other than not related by investigator or company considered a reaction

REPORTING OF SUSARs FROM GLOBAL TRIALS IS COMPLICATED

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Development Safety Update Report (DSUR)

ICH Guideline and format ● Review of new data from

• Pre-clinical studies with any influence on the safety profile

• Completed or interim analyses of clinical trials (both efficacy and safety)

• Related SAEs (expected and unexpected) from all clinical trials

• Discussion of any new signals of risks

• Appropriateness of risk minimisation for known or unknown risks

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Overall benefit risk assessment

● If new ADRs are identified, IB should be updated (substantial amendment)

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