Frontiers in Drug Safety and Regulation is a Scopus-indexed multidisciplinary journal that aims to address potentially emerging issues concerning pharmacovigilance, with special emphasis on how the post-marketing surveillance drives informed regulatory decision process and vice-versa.

Led by Field Chief Editor Prof Gianluca Trifirò (University of Verona, Italy), Frontiers in Drug Safety and Regulation publishes epidemiological, clinical and translational original articles, editorials and reviews across the fields of clinical pharmacology, pharmacovigilance, pharmacoepidemiology, drug policy, public health and regulatory science. Topics of interest include:

advanced methods in pharmacovigilance and pharmacoepidemiology
cardiovascular drug safety
maternal-fetal medicine
respiratory drug safety
rheumatic drug safety
substance-based medical devices
vaccine safety and regulation

Drug safety monitoring is an essential element for the effective and safe use of medicines and for high quality medical care and it is the process of detection, assessment, understanding and prevention of side effects, allowing an in-depth knowledge of the benefit-risk profile of conventional drugs and vaccines as well as Advanced Therapy Medicinal Products (ATMPs, e.g., gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered medicinal products, medicinal products for combined advanced therapies,), dietary supplements/nutraceuticals and medical devices.

Regulatory science refers to the range of scientific disciplines aimed at assessing the quality, safety and efficacy/effectiveness of medicinal products and informing regulatory decision-making throughout the lifecycle of a medicine. It comprises basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.

In particular, the journal welcomes submissions which support and advance the UN’s Sustainable Development Goals (SDGs), notably SDG 3: ensure healthy lives and promote well-being for all at all ages.

Collaboration between clinicians and basic scientists is strongly encouraged by the editors and papers issued from a collaborative strategy between the academic and the private industrial sectors are welcome.

Manuscripts which do not relate to conventional drugs, vaccines, ATMPs, nutraceuticals and dietary supplements or medical devices, as well as isolated in vitro or in vivo studies that are not linked to clinical evaluations, are not suitable for publication in this journal.

Frontiers in Drug Safety and Regulation is committed to contributing to elevating regulatory sciences with a patient-oriented approach addressing emerging issues concerning drug safety while taking together clinician, regulatory, academic, patient as well as industry perspective. The journal aims to advance developments in the field of drug safety and regulation research by allowing unrestricted access to articles, and communicating scientific knowledge to researchers and the public alike, to enable the scientific breakthroughs of the future.

Enhancing Drug Safety for Pregnant and Lactating Women: Addressing Perinatal Pharmacotherapy Challenges