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

Abstract

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. These plans aim to enhance understanding of a drug's benefit-risk profile and information on risk mitigation and labelling strategies to ensure end-users are aware of the risks that are associated with the product. Per defined health authorities trigger, RMPs are updated with new data such as post-authorisation data and expanded product labels (new indications), leading to multiple versions. When specific risks require additional mitigation beyond product labelling, additional risk minimisation materials (aRMMs) may be applied to educate healthcare professionals (HCPs) and patients. In some cases, more stringent controls on drug use may be necessary. In all cases, these risk management commitments must be implemented in applicable countries where the medicine is marketed following local regulatory requirements. Implementing aRMMs necessitates the distribution of core or EU RMPs and aRMMs to local affiliates for localisation, approval by local health authorities, dissemination, and subsequent collection of effectiveness metrics. Managing multiple versions of core and local RMPs, aRMMs, and associated activities becomes a vital data management issue, requiring efficient tracking of the status of each document and locally agreed activities. This article explores developing and deploying a database-driven RMP and aRMM tracking system. It covers the determination of system requirements, the delivery of the system, and the assessment of its impact on the organisation.