Scope

Regulatory Science, the science behind regulatory requirements for the development of medicinal products, has gained increasing recognition over the past years as a unique scientific discipline.

The need to regulate the principles and requirements for the development and human use of medicinal products has been mainly triggered by some fatal accidents with sulfanilamide elixir (USA, 1937), thalidomide malformations (Europe, 1957) and the more recent catastrophic failures with the CD28 antibody (TGN1420, 2005). The two latter cases in particular have clearly highlighted the need for continuous updating of regulatory guidelines based on the scientific advances behind each developing medicinal product or therapeutic class/target.  The latest clinical trial accident with BIA 10-2474, (France, 2016) point towards the same direction.

Recent scientific advances in human genome decoding and other technological advances have helped researchers design targeted molecules that are modulated according to individual target attributes in diseases such as cancer and others. Additionally, the modeling and simulation capabilities as well as the emerging capacities to record, stratify and bank human samples, patient information (such as electronic health records), etc. is putting into reflection and discussion new approaches for preclinical and clinical studies as well as the early anticipation of models allowing the rationale and cost effective use of the innovative medicines to make it possible for patients and society to access innovation.

Clearly, the flow and accumulation of knowledge on medicines, diseases, and patient-specific attributes, can only be efficiently used for accelerating innovation if some common principles and strategies are shared by the multiple stakeholders involved in the process. The science and knowledge behind those principles constitute the basis of Regulatory Science.

Regulatory Science is focused on the development of policy tools and regulatory standards that would facilitate decision making for regulatory authorities. The ultimate goal is to improve the efficiency and accuracy of these decisions and thereby foster innovations and progress in medicine and patient care.

Regulatory Science is a transversal discipline based on the knowledge generated by the pharmaceutical industry, academia, regulatory agencies, health institutions and health technology systems. Providing a scientific basis for regulatory policies is necessary not only for efficiency but also for improved protection of the general public.

Research findings are routinely used to assess and diminish human health risks associated with the adoption of a new drug, approach or treatment. Conducting and sharing research on new tools and approaches is key to informing regulatory science and impacting its future directions. To better serve the community, research should be published as soon as possible and made readily available to regulators and other stakeholders. A new section of Frontiers in Medicine, Regulatory Science, invites authors to submit their manuscripts dealing with regulatory science aspects in the field of medicine. The key focus areas for the Regulatory Science section of Frontiers in Medicine are the tools that cover the regulation of pharmaceutical medicine, patient treatments and medical devices.

Submission

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