Chinese Pharmacovigilance Landscape – A Shift from Manual to Electronic Systems
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Chinese Pharmacovigilance Landscape - A Shift from Manual to Electronic Systems
One of the key requirements of the new pharmacovigilance legislation (Regulation 726/2004) in the EU is simplified reporting of individual case safety reports (ICSRs) by a Marketing Authorization Holder (MAH) to the new EudraVigilance (EV) system
