FDA and EMA Global Labeling Challenges and Requirements
January 11, 2019 - Online Event ON CA
Pharmaceutical companies should manage the process of designing and creating product labels meeting regulatory requirements. It includes product-labeling documents such as Summaries of Product Characteristics (SmPCs), Packet Inserts (PIs), and Core Data Sheets (CDSs). A large number of dosage forms, product presentations, and product strengths results in a large number of labeling records, which must be maintained and kept synchronized. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have implemented a set of rules for electronic submission of labeling content. As per FDA, the companies are required to submit XML labeling content in Structured Product Labeling (SPL) format. Whereas, the EMA requires companies to submit product information documents in a format that is QRD-compliant.