Scope

Frontiers Regulatory Affairs is a multi-disciplinary section which aims at publishing original and high-quality research on the impact of regulatory requirements in:

• Clinical development
• Novel clinical trials designs
• Benefit-risk profile evaluation methods and frameworks
• Real-world evidence support in clinical development and post-authorization monitoring
• Health technology assessment
• Therapeutic risk management
• Methods to promote/evaluate adherence to practice guidelines/public health measure

Research in regulatory science is continuously evolving through the need for more efficient assessment of medicinal products and medical devices to support regulatory decision making and maintain the positive benefit-risk profile during the entire lifecycle. As science and technology advance, regulatory science must advance in parallel. Examples of the transformational research that is having a significant impact on the regulatory science agenda include cell-based therapies, orphan medicinal products, genomics-based diagnostics, drug-device combinations, novel clinical trial design, in-silico models, real-world evidence and common data models for observational research, artificial intelligence. Research on all these issues is welcomed, both applied and methodological.

Requirements for marketing authorizations and reimbursements all face specific and common challenges, either for conventional medicinal products or for new highly specialized technologies. Regulators and other stakeholders have developed and implemented structured benefit-risk frameworks to aid decisions and communication about benefits, harms, and uncertainties. Health economic considerations play a major role in determining patient access to medicines. Regulatory Affairs welcomes research aiming to bridge the gap between the regulatory requirements for the registration, post-authorization monitoring, and reimbursement of any type of health technology.

Alongside practical issues for regulation, Regulatory Affairs aims to enhance methodologies and related discussions. Overall, Regulatory Affairs aims to bring the worlds “clinical development”, “marketing authorization”, “reimbursement”, “post-authorization monitoring”, “medical adherence” 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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