COMPARATIVE PATHWAYS: RELIANCE & CONVERGENCE FOR MEDICINES AND MEDICAL DEVICES

2026 Open access

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Authors: Piyush Modi, Krishna Patel, Jigneshkumar Modasiya
DOI: 10.34218/ijms_04_01_002
Cited by: 0

Abstract

This article explores how global regulators are increasingly adopting common standards and collaborative review processes to enhance patient access without undermining independent national decisions.It consolidates current authorization pathways for medicines and medical devices in the US, EU, UK, Japan, China, South Korea, Singapore, Brazil, Mexico, Saudi Arabia, and South Africa.It also details how reliance mechanisms such as Project Orbis, the Access Consortium, the WHO's Collaborative Registration Procedure, and MDSAP can be integrated into a unified global strategy.

Fields of Study & Subjects

Healthcare Regulation Pharmaceutical Economics and Policy Biomedical Ethics and Regulation

Publication details

Volume
4
Issue
1
Pages
9–25
Publication date
12 February 2026
Language
EN