In 1987, Uchiyama defined “regulatory sciences” as the process for assessing scientific optimization and technologi- cal developments through accurate prediction, evaluation, and decision-making process, based on scientific evidence with the aim to impact human health. For the past thirty years, within the context of regulations, both for medicines and medical devices, the term regulatory sciences has been evolving proactively. Essentially, regulatory sciences have helped to optimize the analysis of regulations within the scientific regulatory landscape, adapting to and promoting innovation. Also, regulatory sciences as a component of scientific knowledge and thinking, it is a paramount tool.
harmonizing the dialogue between health agency regulators and key stakeholders, including the research industry, aca- demia, manufacturers, distributors of medicines and medical devices. Regulatory science supports the accelerated devel- opment of products that can positively impact healthcare globally.
On one hand, we are clearly witnessing the emerging potential of innovative medicines, therapies and technolo- gies to help advance population health and quality of life. These innovative products can provide effective treatment for a specific illness with significant improvement over exist- ing treatments or providing a verifiable therapeutic option for diseases where there is no effective treatment or in a subgroup of patients with unmet medical needs.
