Development of Post-Marketing Risk Management Plan Requirements: The Singapore Experience
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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.
We thank Dr. Dorothy Toh for her support and guidance and Ms Jalene Poh and Ms Adena Lim for their advice regarding this manuscript.
No funding was received specifically for the publication of this article.
Compliance with Ethical Standards
Conflict of interest
Liesbet Li-Bei Tan, Christine Su-Ching Ho, Phey-Yen Han and Cheng-Leng Chan declare that they have no conflict of interest that is directly relevant to the content of this article. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the Health Sciences Authority or any of its committees or working parties.
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