Journal Highlight : Regulatory Science
The journal welcomes scholarly contributions related to the scientific, regulatory, ethical, and policy frameworks that support the development, evaluation, approval, quality assurance, and post-market monitoring of pharmaceutical and healthcare products. This section focuses on research that advances evidence-based regulatory practices, strengthens healthcare compliance systems, and promotes innovation, safety, and quality in pharmaceutical sciences and drug development.
The journal encourages submissions in areas including Pharmaceutical Regulatory Affairs, Drug Approval and Compliance Processes, Quality Assurance and Quality Control, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Regulatory Toxicology, Clinical Trial Regulations, Pharmacovigilance and Drug Safety Regulations, and Biopharmaceutical Regulatory Standards. Research related to Medical Device and Diagnostic Regulations, Biosimilars and Biologics Regulation, Regulatory Policies for Advanced Therapeutics, Global Harmonization Standards, and Ethical and Legal Aspects of Healthcare Regulation is also welcomed.
Submissions focusing on AI and Digital Technologies in Regulatory Science, Real-World Evidence and Regulatory Decision-Making, Risk Assessment and Benefit–Risk Evaluation, Data Integrity and Regulatory Compliance, Precision Medicine Regulatory Frameworks, Regulatory Innovation in Drug Development, Healthcare Policy and Governance, and International Pharmaceutical Regulations are encouraged. The journal also welcomes studies investigating regulatory strategies, quality systems, clinical and post-market evaluation methods, and evolving regulatory approaches for emerging pharmaceutical and biomedical technologies.
Accepted manuscript types include Original Research Articles, Systematic Reviews, Meta-Analyses, Policy and Regulatory Analyses, Clinical and Industrial Studies, Methodology and Technical Reports, and Translational Pharmaceutical Research Articles that contribute to advancements in regulatory science.
Through this focus area, the journal aims to support research that strengthens regulatory and quality systems in healthcare and pharmaceutical sciences, advances evidence-based policy and compliance practices, improves product safety and therapeutic effectiveness, and contributes to innovation in global pharmaceutical and biomedical regulation.
