Regulatory Reliance and Recognition in Pharmaceutical Product Registration: A Critical Comparative Review of Collaborative Assessment Pathways, Accelerated Approvals, Evidence Requirements, and Regulatory Decision-Making Across the United States, United Kingdom, Australia, and the United Arab Emirates
Year: 2026
Type: article
Abstract: Regulatory reliance and recognition pathways have emerged as transformative strategies for global regulatory frameworks, aiming to optimize resource allocation, eliminate duplication of effort, and accelerate patient access to safe, effective, and high-quality pharmaceutical products. This critical comparative review provides a comprehensive analysis of the regulatory frameworks of seven major jurisdictions: the United States (USA), the United Kingdom (UK), Australia, Switzerland, Germany, South Korea, and the United Arab Emirates (UAE). By dissecting the reliance mechanisms, expedited approval pathways, Good Manufacturing Practice (GMP) compliance models, post-approval variation lifecycles, and ongoing regional harmonization efforts, this study identifies critical structural gaps and proposes actionable operational strategies. The findings underscore that while unilateral reliance benefits resource-constrained settings, mutual recognition agreements (MRAs) and complex collaborative frameworks among high-maturity authorities are vital for sustainable international public health ecosystems.
Institution: Pravara Institute of Medical Sciences
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7224108056