Definition

A yearly safety report required by some regulatory authorities, summarizing safety data and any relevant safety issues.

Example

Japan requires Annual Safety Reports for approved products, summarizing Japanese and global safety data with analysis relevant to the Japanese population.

Regulatory source

Regional Requirements

Common mistakes

Assuming PSUR meets all regional annual reporting requirements without checking specific local formats.

Inspector question

What regional annual reports do you prepare? How do they differ from PSURs?

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