The Regulatory Department: An Agent for Knowledge Sharing and Process Change

Abstract

The Regulatory Department is sometimes unfairly seen as a bottleneck in the process of getting a new drug to market. Perhaps this is a natural response given their pivotal role in ensuring compliance of all manner of aspects of the drug compound discovery through to manufacture and distribution. However, it is reasonable, given the internal and external pressures upon this department to change, that the Regulatory Team has the potential to significantly change and improve their impact upon the whole approval process. The changes that they face can lead to an opening up of company knowledge and content. The following paper describes the situation that the Regulatory Departments currently face. It considers how the electronic Common Technical Document (eCTD) is causing change and offering the potential for process change, not just in the Regulatory Department but also in other departments of both Research & Development (R&D) and Manufacturing.