Tracking a Medicine's Regulatory Risk Management Commitments Provides Better Transparency and Oversight.

Pharmaceutical companies are required to provide Risk Management Plans (RMPs) to support the marketing authorisation of medicines. These RMPs contain information on efficacy and safety, outline risks or gaps in information, and detail commitments for post-authorisation pharmacovigilance (PV) studies...

Full description

Bibliographic Details

Published in:	Therapeutic Innovation & Regulatory Science Vol. 59; no. 5; pp. 901 - 909
Main Authors:	Ingate, Simon, Bendall, Kate, Long, Christopher, Fetterman, Kevin, Liles-Burden, Marie, Strauss, Carmit
Format:	research tables/charts Journal Article
Published:	Springer Nature Sep2025
Online Access:	View this record in EBSCOhost