Industry Pushback Prompts EMA to Ease Postmarket Monitoring, Reporting

New guidance proposed by the European Medicines Agency addresses industry concerns that the EU’s 2010 pharmacovigilance law requires overly burdensome postmarket monitoring and reporting. The guideline specifically deals with Module VI of the good pharmacovigilance practices, or GVP, guideline, which lays out requirements for managing and reporting adverse events.
International Pharmaceutical Regulatory Monitor