EU ministers further strengthen proposed pharmacovigilance rules, as UK MHRA posts handy guide
This article was originally published in SRA
Executive Summary
The European Parliament's influential environment and public health committee (ENVI) has voted through the European Commission's new proposals on pharmacovigilance, which include an automatic urgent procedure when safety alerts are issued, and tighter obligations on companies to inform the regulatory authorities when products are voluntarily withdrawn from the market1,2.