Regulators push to establish a high level of interoperability across global regulatory and healthcare communities. The social demand for higher and higher levels of health care, constant improvement of quality of life and better medicines puts a positive pressure on the healthcare and pharmaceutical systems. Global health emergencies contribute to amplifying the natural urge for health care and high-quality therapeutic solutions to be rapidly made available. The development of new medicines and improvement of existing ones requires new tools to evaluate and predict the efficacy and safety of medical products. However, the development of such tools requires collaboration and effective data sharing (Thompson et al., 2021). In this landscape, the value of an effective data exchange is priceless. Thus, interoperability of regulatory information systems takes on the value of an essential requirement for regulatory bodies.
Interoperability guarantees different information systems to access, integrate information, share and cooperatively use data in a coordinated manner, within and across organizational, regional and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally (HIMSS Definition). The primary expectations in sharing databases is to ensure consistency of data in national and central databases, minimize additional administrative burdens to keep data synchronized between national authorities and enable the automatization of data exchange.