Pilot extension in EVDAS

The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor the data published in Eudravigilance and to inform the Agency and National Competent Authorities (NCA) of validated signals detected in the database.   On November 22, 2017, it allows to access to the database  (EVDAS) includes in EudraVigilance that allows MAH to…

Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a challenge for the pharmaceutical industry. Based on the document ‘Implementation strategy of ICH Q3D guideline’ (EMA/CHMP/QWP/115498/2017 – Committee for Medicinal Products for Human use (CHMP), there are two different approaches to risk management of elemental impurities…