Considering the broad regulatory experience as well as the experience on IT solutions in the drug regulatory affairs area, the BfArM assigned contribution to the PharmNet.Bund project, which became the major task for now. The long-term experience of clinical assessment of marketing authorization applications and their presentation to the general public, substantial experience in assessing package leaflets, readability tests, and other forms of technical presentation of the content of package leaflets and SmPC will contribute to constitute useful functionalities of the portal for medical products, called PharmNet.Bund. In addition, long-term experience in electronic submissions of different formats and the engagement in contributing to the development of the eCTD next major version (v 4.0) based on HL7 RPS message standard are other major activities. “Limited human resources, high workload and extended transparency will require support by electronic tools. These tools are only effective in case harmonization of data concepts, processes, and software interoperability are assured” ― Dr. Klaus Menges