Definition

The date of first marketing authorization for a medicinal product anywhere in the world, used to calculate PSUR submission intervals.

Example

Drug X was first approved in Switzerland on June 15, 2010. This IBD determines that PSURs are due in December (6-month cycle) and June (annual) regardless of when other countries approved.

Regulatory source

ICH E2C(R2)

Common mistakes

Using regional approval dates instead of the global IBD for PSUR timing, leading to inconsistent reporting periods.

Inspector question

How do you determine and track IBDs? How do you handle products with different formulations?

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