Reviewing EMA’s Revised Guideline on Manufacture of the Finished Dosage Form

published 15 May 2019

Source: Regulatory Rapporteur – Vol 14, No 9, September 2018

Authors: Tessa Fiorini Cohen, Claire Corinne Azzopardi, Michelle Gafa

A recently published Regulatory Rapporteur article from our sister company Real Generics Ltd, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments received by the EMA during the associated consultation period.

Please read the full article herein

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