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Advances in pharmacovigilance and benefit-risk management have refined risk minimization measures (RMMs). This article details progress in RMM design, implementation, and evaluation, suggesting global harmonization for better drug safety.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Benefit-Risk Management
  • Regulatory Science

Background:

  • International Conference on Harmonisation (ICH) E2E and Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidelines enhanced pharmacovigilance.
  • Significant scientific and practical advancements have occurred in risk minimization measures (RMMs) since these guidelines were released.
  • Focus has shifted to the design, implementation, dissemination, and real-world effectiveness evaluation of RMMs.

Purpose of the Study:

  • To describe advancements in the design, implementation, dissemination, and evaluation of RMMs.
  • To highlight current challenges and propose potential solutions in RMM practices.
  • To advocate for global harmonization in specific aspects of RMMs.

Main Methods:

  • Review of recent advances in the science and practice of RMMs.
  • Analysis of evidence-based approaches informing RMM development.
  • Inclusion of global examples illustrating effective RMM strategies.
  • Consideration of local healthcare system policies and national legislations.

Main Results:

  • The field of RMMs has progressed significantly in design, implementation, dissemination, and evaluation.
  • Evidence-based approaches are increasingly informing the development of RMMs.
  • Global examples demonstrate successful implementation of advanced RMM strategies.

Conclusions:

  • There is a need for a global effort to harmonize specific areas of RMMs.
  • Harmonization should focus on standardizing terms, definitions, and methodologies.
  • Best practices for RMM design, implementation, and dissemination require outlining.