Monthly Archives: October 2018

Deconstructing the revised EMA guideline on manufacture of the finished dosage form

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company Real Generics Ltd, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising […]