Regulatory Labeling regulations are essential for ensuring compliance of drug products to be used safely and with efficacy by patients. However, regulatory labeling compliance requirements can differ across regions and new regulations are routinely being introduced to update labeling documents. Prescription drug labeling includes the core safety and clinical information about a drug product, often in the form of a local regional label for example Summaries of Product Characteristics (SmPC); United States Production Information (USPI) or Product Monograph (PM); or, expressed as a global company core document such as Company Core Data Sheet (CCDS).
Guidance mandates and recommendations are issued for each different aspect of labeling, such as clinical labeling, dosage and administration, warnings and precautions, adverse reactions and general guidance with respect to therapeutic group classes. This makes global and regional labeling management a complex and time-consuming activity for life sciences companies to ensure consistency and compliance across the concerned regions.
Our team of highly qualified medical experts can help ensure that the most up to date information is expressed in the labeling documentation to patients and healthcare practitioners.