Safety surveillance has evolved into a continuing process during the whole drug life cycle. Policy-makers and regulatory bodies have instigated proactive safety assessments during drug development by mandating the manufacturers to submit risk management plans (RMPs). The RMP lays out a schematic platform on which the pharmacovigilance plan and risk-benefit analysis are characterised for any drug. In this paper, Mohamed El Malt and Vijayanand Rajendran at Europital discuss how the current risk management principles are woven to shape up a progressive safety profile for a drug, alongside setting a road map for risk minimisation and efficacy evaluation.
Regulatory 1 – Consolidation