UNIT 3: Global Regulatory Submission Pathways
This unit explains global regulatory submission types and approval pathways used to obtain market authorization for pharmaceutical products. It focuses on how submission routes are selected based on product type, development strategy, and regional regulatory frameworks.
Definition
Global Regulatory Submission Pathways refer to the structured routes, requirements, and regulatory processes through which pharmaceutical, biologic, device, and combination products are submitted to regulatory authorities for clinical trial authorization, marketing approval, and post‑approval maintenance across different countries.
Key Points
They ensure safety, efficacy, and quality of therapies.
Allow harmonization of international standards (ICH, WHO).
Facilitate accelerated access for life‑saving drugs.
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