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Updated: Aug 5, 2026
07:55
Using SCOPE to Identify Potential Regulatory Motifs in Coregulated Genes
Published on: May 31, 2011
Regulatory harmonization: Evolution, globalization and future directions
Orin Chisholm1, Elaine Y L Blair2, Christine Y Lu1,3,4
1Sydney Pharmacy School, The University of Sydney, Sydney, New South Wales, Australia.
British Journal of Clinical Pharmacology
|July 28, 2026
Summary
Regulatory harmonization streamlines medicine approvals globally. Initiatives like ICH and WHO advance convergence, enhancing access to safe, effective treatments despite challenges.
Area of Science:
- Pharmaceutical Regulation
- Global Health Policy
- Drug Development
Background:
- Regulatory harmonization is crucial for efficient global medicine access.
- International collaboration aims to streamline drug review processes.
- Evolving healthcare needs demand adaptive regulatory frameworks.
Purpose of the Study:
- To review the evolution and current status of regulatory harmonization, convergence, and reliance.
- To examine global, regional, and collaborative initiatives in pharmaceutical regulation.
- To highlight new approaches and challenges in regulatory science.
Main Methods:
- Literature review of harmonization initiatives.
- Analysis of global frameworks (ICH, WHO, ICMRA, IPRP).
- Examination of regional strategies (ASEAN, PANDRH, AMA, EU) and collaborative models (Access Consortium, Project Orbis).
Main Results:
- Traces harmonization progress from EEC to ICH and global/regional bodies.
- Highlights diverse strategies like ASEAN Joint Assessment and EU Joint Clinical Assessment.
- Demonstrates collaborative models expediting approvals and strengthening capacity.
- Identifies leveraging real-world evidence and regulating advanced therapies as new frontiers.
Conclusions:
- Harmonization enhances regulatory systems and benefit-risk assessments.
- Adaptive, collaborative frameworks are essential for new therapies and evolving priorities.
- Ongoing alignment and convergence are vital for agile global regulatory systems.
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