What is it about?
Getting new medicines and medical devices approved can take a long time because each country usually reviews them separately. This can delay access for patients who need treatment. This paper explains how regulators around the world are starting to work together more closely to speed up this process. Instead of repeating the same work, some countries now rely on evaluations already done by trusted agencies in other regions. The study compares how approvals work in major regions such as the United States, Europe, the United Kingdom, Japan, China, and others. It also describes international programs that allow regulators to share information and review applications at the same time. By using these collaborative approaches, companies can plan smarter global strategies, reduce duplication, and bring new therapies to patients more quickly while still ensuring safety and quality.
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Why is it important?
This topic is important because patients around the world often face delays in accessing new medicines and medical devices due to separate, repetitive regulatory reviews in each country. Improving coordination between regulators can significantly reduce these delays and help ensure faster access to safe and effective treatments. What makes this work particularly unique is that it brings together a detailed comparison of regulatory pathways across multiple major and emerging markets and links them directly to practical reliance and collaboration mechanisms. Instead of describing systems in isolation, it shows how initiatives such as Project Orbis, the Access Consortium, WHO Collaborative Registration Procedure, and MDSAP can be strategically combined into a unified global approach. The work is also timely because global regulatory convergence is rapidly moving from theory to real-world implementation. Many regions are actively introducing reliance-based pathways, digital submission systems, and accelerated approval mechanisms. This creates both opportunities and complexity for companies trying to plan global submissions. By providing a clear, practical framework for sequencing submissions and managing lifecycle changes across regions, this article helps regulatory professionals, industry stakeholders, and policymakers navigate this evolving landscape more effectively. Ultimately, it contributes to the broader goal of improving global access to innovative therapies while maintaining regulatory standards.
Perspectives
From my perspective, the shift toward regulatory reliance and convergence represents one of the most important changes in global healthcare regulation in recent years. Traditionally, companies had to navigate separate and often repetitive approval processes in each country, which created inefficiencies and delayed patient access. The increasing adoption of collaborative approaches signals a move toward a more connected and practical global system. What stands out to me is how reliance is no longer just a theoretical concept but is now being actively implemented across multiple regions through programs like Project Orbis, the Access Consortium, WHO CRP, and MDSAP. The real opportunity lies in how these mechanisms can be integrated strategically rather than used in isolation. In my view, the biggest challenge going forward will not be the availability of these pathways, but how effectively organizations align their internal processes, data strategies, and lifecycle management to take full advantage of them. Companies that adopt a truly global mindset and plan submissions in a coordinated way will be better positioned to succeed. Overall, I believe this evolving landscape represents a meaningful step toward reducing duplication, improving efficiency, and ultimately accelerating patient access to innovative therapies worldwide, while still maintaining high regulatory standards.
Piyush Modi
Amneal Pharmaceuticals LLC
Read the Original
This page is a summary of: COMPARATIVE PATHWAYS: RELIANCE & CONVERGENCE FOR MEDICINES AND MEDICAL DEVICES, February 2026, IAEME Publication Chennai,
DOI: 10.34218/ijms_04_01_002.
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