Scope

Frontiers specialty section Regulatory Affairs aims to bridge the gap between the  regulatory requirements for the registration of medicines, combination products and medical devices, Health Technology Assessment and reimbursement. In the last decade there has been an effort to better align such requirements for efficacy, effectiveness, cost-effectiveness, benefits, toxicity and safety. Regulatory Affairs welcomes papers on both regulatory issues relating to new medical technologies as well as Health Technology Assessment. Topics may concern the whole spectra of trial design to real-world evidence, the use of intermediate to final endpoints, quality-of-life estimation to costing, numbers needed to treat to cost per quality-adjusted life-year and benefit/harm to cost-utility analysis.

Requirements for market authorizations and reimbursements all face specific and common challenges, both for conventional medicines as well as test, aids and appliances and new highly-specialized technologies, such as cell and gene therapies, medicines for ultra-rare diseases, new classes of vaccines, immunotherapies and others. Papers on all these issues are also welcomed, both applied and methodological.

Alongside practical issues for regulation, Regulatory Affairs aims to enhance methodologies and related discussions. These can be in the areas of survival analysis, extrapolations, propensity scoring, quality of life-measurement, cost-effectiveness analysis, probabilistic and uncertainty analyses, ethical philosophies and economic theories. Overall, Regulatory Affairs aims to bring the worlds of technologies' marketing authorization and technologies’ reimbursement closer together, ultimately benefiting the patients with rapidly available, effective, safe, affordable and cost-effective treatments within sustainable health-care systems.

Submission

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