The Use of Real-world Data to Assess the Impact of Safety-related Regulatory Interventions.

Abstract

The regulation of medicines seeks to ensure the efficacy, safety and quality of prescription and non-prescription medicines. Given that the conditions under which a medicine s benefits outweigh its risks are complex, it is essential that communications about the safe and effective use of medicines be clear and actionable. Assessing the impact of interventions to improve the safe and effective use of medicines is a developing area, and one in which real-world data are playing an increasingly important role.