Definition

A safety issue that requires urgent reporting to regulators based on new information that may affect the benefit-risk balance of a product.

Example

A cluster of fatalities from a previously unknown adverse reaction is detected. This emerging safety issue is reported to regulators within 24 hours of identification.

Regulatory source

EU GVP Module VI

Common mistakes

Not recognizing emerging safety issues promptly, or over-reporting minor issues as emergent.

Inspector question

How do you identify emerging safety issues? Walk me through a recent example.

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