EMA’s pilot scheme for academic and non-profit development of ATMPs
by Giuliana Miglierini Advanced therapy medicinal products (ATMPs) are often developed by academic and non-profit organisations, because of…
The first Union list of critical medicines
by Giuliana Miglierini The first version of the Union list of critical medicines was published on 12 December…
Swissmedic’s technical interpretation of Annex 1
by Giuliana Miglierini New insights on the interpretation of the new Annex 1 to Good manufacturing practices (GMPs)…
PIC/S new guidance documents for GDP inspectors
By Giuliana Miglierini Two new guidance documents for GDP inspectors have been issued by the Pharmaceutical Inspection Cooperation…
EMA’s consultation on draft Q&As on remote certification of batches by QP
by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…