Definition

Adverse event reports submitted directly by healthcare professionals or patients to regulatory authorities, bypassing the pharmaceutical company.

Example

A patient reports an adverse reaction directly to FDA via MedWatch Form 3500. The FDA may forward this report to the manufacturer for additional information.

Regulatory source

EU Pharmacovigilance Legislation, FDA MedWatch

Common mistakes

Not having processes to receive and reconcile reports forwarded from regulatory authorities.

Inspector question

How do you handle reports received from regulatory authorities that were originally submitted by HCPs or patients directly?

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