Definition

Country-specific adverse event reporting obligations that may differ from international standards in terms of reportability criteria, timelines, or format.

Example

Some countries require reporting of non-serious expected events, different timeline calculations, or local language translations not required by ICH standards.

Regulatory source

National Regulations

Common mistakes

Applying only ICH standards without checking specific local requirements, leading to non-compliance in certain markets.

Inspector question

How do you identify and track local reporting requirements? Give examples of requirements that differ from ICH standards.

Related terms