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Global Pharmaceutical Regulation: Comparative Frameworks and Operations.

Omolayo Tinuke Umaru1, Adebowale Sylvester Adeyemi1, Olajumoke Aderonmu2

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Pharmaceutical regulation ensures public health by overseeing medicines. Global regulators show increasing convergence in scientific standards, but differences persist in legal frameworks and timelines, impacting complex drugs and crisis responses.

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Area of Science:

  • Pharmaceutical Regulation
  • Public Health Policy
  • Global Health Governance

Background:

  • Established pharmaceutical regulatory systems like the FDA, PMDA, and EMA are well-documented.
  • Comparative analyses integrating mature, emerging, and harmonized regulatory networks are limited.
  • Understanding global regulatory functions is crucial for medicine lifecycle management.

Purpose of the Study:

  • To compare core regulatory functions across diverse global jurisdictions.
  • To analyze convergence and divergence in pharmaceutical regulation.
  • To identify opportunities for strengthening regulatory resilience and equity.

Main Methods:

  • Narrative review of primary regulator/network documentation.
  • Targeted review of peer-reviewed literature.
  • Comparative analysis of regulatory functions including approval, oversight, transparency, and pharmacovigilance.

Main Results:

  • Increasing convergence in scientific expectations driven by initiatives like the International Council for Harmonisation (ICH).
  • Persistent differences in legal mandates, resources, timelines, and data requirements across regulatory bodies.
  • Differences in regulation are most impactful for advanced therapies and during health crises.

Conclusions:

  • Opportunities exist for strengthening regulatory resilience through fit-for-purpose harmonization.
  • Investment in enabling infrastructure and interoperable data systems is recommended.
  • Coordinated post-marketing evaluation and signal detection are key for future regulatory efforts.