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Indexed In

Open J Gate Genamics JournalSeek RefSeek Hamdard University EBSCO A-Z OCLC- WorldCat Publons Geneva Foundation for Medical Education and Research Euro Pub Google Scholar

Open Access Journals

Journal of Mental Health and Psychiatry Journal of Cardiology Journal of Stem Cell Research Therapeutics Advances in Cancer Chemotherapy Journal of Urology Nephrology Journal of Pediatrics Neonatal Biology Journal of Virology Immunology Journal of Endocrinology Journal of Otolaryngology Journal of Plastic Surgery Journal of Vision Science Journal of Gastroenterology and Hepatology Journal of Women Health Journal of Nursing and Health care Journal of Analytical Chemistry Journal of Physical Chemistry Journal of Mass Spectrometry Journal of Polymer Chemistry Journal of Advanced Chemical Engineering Journal of Medicinal Chemistry Journal of Organic and Inorganic Chemistry Journal of Nano Science and Nanotechnology Journal of Material Science Research Journal of Applied Sciences Journal of Business and management Journal of Accounting Research Journal of Industrial Management Journal of Librarian Science Journal of Artificial Intelligence and Machine Learning Journal of Pharmaceutical Research Journal of Drug Discovery and Research Journal of Food Science and Food Safety Journal of Pollution Climate Change Journal of Environmental Chemistry Journal of Geosciences Journal of Food Agriculture Journal of Robotics Research Journal of Humanoid Robotics Journal of Robotic Intelligence and Automation Journal of Genetics and Molecular Biology Journal of Dental Sciences Journal of Aging Science Journal of Bacteriology Parasitology Journal of Biology and Medicine Journal of Biomolecular Research Therapeutics Journal of Fermentation Technology Journal of Eye Diseases and Disorders Journal of Forensic Biomechanics Journal of Plant Pathology Journal of Stem cell Research and Therapy Journal of Food Microbiology

Regulatory Science and Drug Approval Pathways

Regulatory science plays a critical role in translating scientific discoveries into safe, effective, and high-quality medical products. It involves the application of biological, chemical, clinical, and statistical knowledge to evaluate the safety, efficacy, and quality of drugs, vaccines, and biologics. At its core, regulatory science supports public health by shaping the drug approval pathways that guide how new therapies reach patients.

Regulatory science encompasses the tools, standards, and frameworks used by regulatory authorities such as the U.S. FDA, EMA (Europe), PMDA (Japan), and CDSCO (India) to assess and oversee pharmaceutical development. It includes preclinical evaluation, clinical trial design, benefit-risk assessment, pharmacovigilance, and lifecycle management.