Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

Abstract

Notwithstanding successful harmonization efforts, the global regulatory framework governing product safety is complex and continually evolving, as evidenced by additional regional guidance and regulations. In this regulatory review, we provide an overview from both global and regional perspectives. A historical perspective, with a focus on recent developments, enables identification of important long-term trends, such as a shift from single-case medical review of serious adverse events to an interdisciplinary evaluation of aggregate data for the purpose of judging product causality and informing benefit-risk assessments. We will show how these trends lead to opportunities for closer interdisciplinary collaboration, for bridging the gap between preand postmarketing surveillance, and for a more proactive determination of patient populations with a positive benefit-risk profile for product use. We will conclude by pointing to ongoing and future work that seeks to provide specific solutions for ongoing aggregate safety evaluation.

Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities

“…The need for global harmonization of benefit-risk legislation continues to evolve [ 36 ], including the 2016 International Council for Harmonisation revision of the content of Common Technical Document ICH M4E(R2) Section 2.5.6 “Benefits and Risks Conclusions” [ 37 ]. The revision includes division into sections on therapeutic context, benefit, risk, and the benefit-risk assessment, which must now succinctly and critically communicate the benefits and risks of the product.…”