ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER)

We have adopted this International Scientific Guideline – ICH E2C (R2); EMA/CHMP/ICH/544553/1998

Last updated

29 August 2024

About this guideline

Overseas effective date: January 2013

Replaces: CPMP/ICH/4679/02 (Addendum to ICH E2C - CPMP/ICH/288/95)

Categories: ICH | Efficacy | Clinical safety

TGA Annotations: Nil

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