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WHO, reliance, harmonisation concepts, and cross-region submission practices
5 terms
A Council of Europe body supporting the European Pharmacopoeia and issuing CEPs, contributing to quality standards used across Europe and beyond.
A quality system for nonclinical laboratory studies to ensure the quality and integrity of data submitted to regulators.
A collective term for regulated “Good Practice” quality guidelines (e.g., GMP, GCP, GLP) intended to ensure product quality and data reliability.
Alignment of technical and regulatory requirements across regions to reduce duplication and support consistent standards (e.g., through ICH).