Development of Post-Marketing Risk Management Plan Requirements: The Singapore Experience

Abstract

Historically, global drug safety regulations were generally reactive and post-marketing safety monitoring comprised mainly spontaneous adverse event reporting. As a strategic move towards proactive pharmacovigilance, several drug regulatory agencies have introduced requirements for risk management plans (RMPs) since the early 2000s. The aim of this paper is to share the process on how the Health Sciences Authority (HSA), the national drug regulatory authority of Singapore, conceptualised and implemented its local RMP requirements, drawing upon the experiences of international regulatory agencies. Some of the steps taken include the incorporation of local RMP requirements into HSA’s guidance documents for the pharmaceutical industry, consultation with industry stakeholders on the proposed updates to these requirements, and strengthening of the enforcement of RMP requirements through relevant enactments in legislation. We also compared our requirements with that of other regulatory agencies to ensure that they were aligned with global regulatory standards. Based on our experience in developing the regulatory framework for RMP requirements in Singapore, we put forth recommendations which could be useful for other regulatory agencies embarking on the implementation of RMP requirements in their countries.