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Evolving Global Regulatory Frameworks for Drug Discovery and Development: Harmonization and Future Directions.
Virendra S Gomase1,2,3, Rupali Sharma1, Suchita P Dhamane3
1Department of Pharmaceutical Sciences, Amity Institute of Pharmacy, Amity University, Pachgaon, Manesar, Gurugram, 122413, Haryana, India.
Current Drug Discovery Technologies
|May 21, 2026
Summary
Global drug regulatory harmonization streamlines clinical trials and resource use. However, challenges persist in post-market surveillance and AI/ML regulation, necessitating robust risk-based frameworks for efficient drug development.
Area of Science:
- Drug regulatory affairs
- Global health policy
- Pharmaceutical development
Background:
- Evolving global regulatory frameworks aim for harmonization to simplify drug discovery and development.
- International Council for Harmonisation (ICH) guidelines and digital standards like CTD/eCTD show significant convergence in drug applications.
- Despite convergence, regional differences and dissonance persist in regulatory approaches.
Purpose of the Study:
- To examine regulatory changes and harmonization strategies worldwide.
- To analyze lifecycle management and accelerated review pathways across different regions.
- To assess surveillance capacity and comparative metrics in drug regulation.
Main Methods:
- Systematic literature review focusing on qualitative and case study analysis.
- Examination of global and regional harmonization initiatives.
- Comparative analysis of regulatory metrics and surveillance capacities.
Main Results:
- Global and regional harmonization initiatives reduced redundant clinical trials by 25-40%, improving resource efficiency.
- Asia Pacific and China show reduced oncology lifecycle model approvals (20-30%) but increased oncology trial approvals (50-60%).
- These regions lag in filing, enforcement, and technological adaptation compared to global standards.
Conclusions:
- Harmonization reduces data redundancy but regulatory divergence remains a challenge, particularly in post-market surveillance and AI/ML.
- Variations in regulatory philosophy necessitate robust, risk-based frameworks for efficient and safe drug development.
- Future drug regulation requires harmonizing accelerated pathways with enhanced post-market surveillance and addressing local regulatory environments.
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