Good Regulatory Practices in the Regulation of Medical Products

Author(s)	Mr. KUNAL SUNIL NIPHADE, Ms. TRUPTI SANTOSH MORE, Ms. MAYURI AJIT PAGAR, Ms. POOJA NANDKISHOR GADKARI
Country	India
Abstract	Good Regulatory Practices (GRPs) represent a set of internationally recognized principles and tools that ensure regulations are transparent, consistent, evidence-based, and proportionate. Within the field of medical products, medicines, vaccines, medical devices, and diagnostics, GRPs play a critical role in strengthening regulatory systems, facilitating harmonization, and improving public access to safe, effective, and quality-assured products. This review explores the principles of GRPs, their application in medical product regulation, challenges in implementation, international case studies, and future perspectives.
Keywords	Good Regulatory Practices, Medical product regulation, WHO GBT, ICH guidelines Regulatory harmonization, NRAs, Transparency in regulation, Pharmacovigilance Regulatory reliance, Quality assurance, Drug approval, Medical device regulation.
Field	Medical / Pharmacy
Published In	Volume 16, Issue 4, October-December 2025
Published On	2025-11-19
DOI	https://doi.org/10.71097/IJSAT.v16.i4.9512
Short DOI	https://doi.org/hbb8gk

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