Abstract
The constant adjustment of pharmaceutical labeling to accurately portray the benefit, risk, and appropriate usage is a task that will continue to grow. Coordination of multilingual text across the EU markets will remain a challenge, as will coordination with other global markets. Literally thousands of coordination and execution steps are done today in a highly manual and labor-intensive way. The geographically and organizationally distributed stakeholders often follow largely diverting procedures. Managing global product information efficiently depends largely on how the central labeling group and the local affiliates organize their interaction. The availability, capacity, and skills of the local organizations; the product portfolio; the commercial value of a product; the commercial status of the target market; and status of the submission (new product vs maintenance work) influence how the thousands of multilingual tasks are best distributed among centers, affiliates, and external service providers. This paper provides guidelines on how the various methods of local control, local outsourcing, or central outsourcing can be best applied and what the potential risks of each of those methods are. The article further addresses the potential to significantly lower the workload through applying translation technologies and to increase the efficiency of coordinating global labeling maintenance.