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Regulatory Harmonization in Medicine

Meaning

Regulatory Harmonization in Medicine is the collaborative process of aligning the disparate legal requirements, technical standards, and administrative procedures across various national and regional regulatory bodies that oversee medical products and clinical practices. The fundamental goal is to facilitate the efficient, global development, approval, and distribution of demonstrably safe and effective medicines and therapeutic protocols. This alignment streamlines the regulatory process, reduces redundant testing, and accelerates patient access to innovative treatments worldwide.