Regulatory Information - Submission and Management (Article 57(2) of Regulation EC no. 726/2004)

Abstract

It’s the regulator’s and industry’s top priority to monitor the safety of the approved medicinal products. The Eudravigilance system was started by the EMA in 2001 that enabled industry and the agency to electronically transfer safety messages in the form of an internationally agreed exchange format. In order to achieve better product oversight surveillance and interoperability across the community, the agency implemented Article 57(2) in 2012, setting itself on a journey of digitization. It has increased the agency’s focus on using and harmonizing the data as a part of regulatory activities. The overload of complying with agency’s regulations can fall unjustifiably on small business entities as they lack the resources to keep them updated with the latest regulations and its requirements, but the strong exertions of agency and industry have resulted in major positive changes in the pharmacovigilance activities. The agency is influencing the use of controlled vocabulary and defined datasets to secure further activities within the community, with the priority for increased accuracy in signal detection. Together with the industry, the agency has been on an interesting expedition. The agency’s change in the reliance of data for review purposes will alter the operating model within the industry and agency. To ensure uniform data analytics and exchange of the information within the community, the use of real-world data such as patient registries needs harmonized standards and information models. With the support of standardized initiatives such as ISO IDMP, the agency is slowly building a data-driven method towards regulatory activities and processes.