EMA’s new Guideline on the Implementation of the ICH Q3D

On 8 March 2017, the EMA published the guideline “Implementation strategy of ICH Q3D”. The final version contains notable changes: (I) analytical methods have to be validated for the intended purpose, (II) a summary of the risk assessment has to be submitted in the marketing authorisation dossier, (III) If limited knowledge of the possible sources routine testing for all elements has to be performed, and (IV) both approaches “Drug Product Approach” and “Component Approach” are accepted.