Definition

Measures taken by regulatory authorities in response to compliance issues, ranging from warning letters to product withdrawal.

Example

Following critical inspection findings, regulatory actions could include: warning letter, consent decree, import alert, marketing suspension, or license revocation.

Regulatory source

Regional Regulations

Common mistakes

Underestimating the potential consequences of pharmacovigilance non-compliance.

Inspector question

What regulatory actions are you aware of in your therapeutic area? How do you prevent similar issues?

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