Definition

A government agency responsible for regulating medicines, including receiving safety reports and taking regulatory action to protect public health.

Example

Key regulatory authorities include FDA (US), EMA (EU), PMDA (Japan), MHRA (UK), and Health Canada. Each has specific reporting requirements and formats.

Regulatory source

Regional Regulations

Common mistakes

Assuming all regulatory authorities have identical requirements. Regional variations in timelines, formats, and reportability exist.

Inspector question

How do you track different regulatory authority requirements? How do you stay current when requirements change?

Related terms