Ensuring regulatory and scientific compliance with the requirements of the Common Technical Document (CTD) of data generated by manufacturers or manufacturing consortia

by Michael Pfleiderer

Manufacturers of medicinal products operating within and outside the European Union (EU) or the European Economic Area (EEA) who aim at placing their products on the EU/EEA market often find it difficult to correctly interpret data requirements for a valid CTD. Uncertainties on the amount and quality of scientific data to be generated and on the way how to optimally present these data within the individual sections of the CTD very often create a major hurdle that cannot be overcome easily. Most notably, uncertainties and discrepant opinions on these issues can significantly complicate partnering processes between two or more enterprises that are dependent on each other for successful drug development and licensure.