UNIT 1: Foundations of Regulatory Affairs
This unit introduces the fundamentals of Regulatory Affairs, explaining its purpose, scope, and importance in protecting patient safety and ensuring regulatory compliance. It also covers the historical evolution of drug regulations and the strategic role of Regulatory Affairs professionals across the product lifecycle.
Definition
Regulatory Affairs is the discipline responsible for ensuring that pharmaceutical products comply with applicable laws, regulations, and guidelines throughout their development, approval, and post-marketing lifecycle.
Regulatory Affairs acts as the scientific, legal, and strategic interface between pharmaceutical companies and regulatory authorities. RA ensures that data generated during drug development is acceptable for regulatory review, approvals are obtained efficiently, and products remain compliant throughout their lifecycle. The function directly influences approval timelines, compliance status, and patient safety.
Key Points
Protects patient safety and public health
Ensures legal approval and market continuity
Supports product development and lifecycle management
Aligns scientific evidence with regulatory expectations
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