The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).
The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).