Label Tracking: An Important Aspect In Production Distribution

1. B l o g A r t i c l e Label Tracking: An Important Aspect In Production Distribution Drug labelling has changed over time because of evolving regulations and has increased in content and length, with a standard format to guide the safe and effective use of the drug. Product labels (drug or devices) contain comprehensive information enriched with product details, such as disease indications, target populations, drug-drug interactions, and ADRs. The labels and labelling documents prepared by manufacturers and approved by the Health Authorities, in its final form, reflect the collective input from regulators, drug manufacturers, and scientific experts. Drug-labelling data is an important resource for diverse applications, including support for policy development. The global labelling management process continues to be a burden on the life sciences industry and is multiplying at a pace that is already becoming increasingly difficult to manage. Firms’ R&D ambitions are growing, businesses are expanding into multiple markets, and regulators are steadily strengthening safety requirements to protect patients and public health. The pharmaceutical industry operates on a global scale, and regulatory compliance across multiple geographies is fundamental to ensuring that the supply chain remains safe and secure. As part of the dossier registration, all manufacturers must submit labelling support documents (USPI, SmPC, PIL, IFU, etc.) to HAs to grant marketing approval. Each time the benefit and risk profile or safety factors change, or as regional or local regulatory agencies update their standards, international biopharmaceutical firms must react swiftly with accurate, compliant labelling for all affected markets. This is a real-time and hectic process for multinational companies as there are major content interdependencies. Moreover, managing the local label changes (CCDS vs USPI, SmPC & other local labels) with company core safety information i.e. how a change anywhere along the safety-regulatory-manufacturing-supply chain continuum will affect all label content, from the global core datasheet, to patient-facing product information in each marketed country. Read Full Article www.DDIsmart.com