6th DIA China Annual Meeting

Drug product labeling summarizes the essential scientific information needed for the safe and effective use of the drug and is the primary source of information about a drug’s safety and effectiveness. Multinational pharmaceutical companies develop the core label for each of their drug products, ensuring the consistent communication of safety information across the countries. The core label is a living document – the change will occur anytime when new information is identified, particularly the new safety information, leading to the downstream label updates in the countries where the product is marketed. On the other hand, there have been increased numbers of safety labeling changes requested by the Health Authorities - namely if the Agency becomes aware of “new safety information” that it believes “should be included in the labeling of the drug, ” then it may trigger a process to rapidly amend the labeling for the product. Our session aims to provide an overview on what constitutes the label, how the label evolves, and safety label updates in the context of the continuous benefit/risk assessment. Otherwise, we will touch upon the practical challenges faced by the multinational companies in implementing the company core label. Also, the audience will hear the perspectives of the Health Authorities in China and EEA countries on the role of the label in communicating product safety information.