ISSN2320-2882
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Paper Title
A REVIEW ON REGULATORY AFFAIRS
Authors
Shubham Rajendra Chavan , Dr.Vijaykumar Kale , Dr.Mahesh Thakare , Mr.Vaibhav Narwade , Ms.Vaishnavi K. Chivte
Keywords
Drug Regulatory Affairs, Regulatory Agencies, ICH Guidelines, Harmonization, Pharmacovigilance, Global Collaboration, Drug Approval Pathways, Regulatory Science, Clinical Trials, GMP, Drug Safety.
Abstract
A key component of contemporary pharmaceutical governance is Drug Regulatory Affairs (DRA), which guarantees that medications entering the healthcare system are safe, efficient, and produced in accordance with strict quality standards. The regulatory environment now covers complex medicines including biologics, biosimilars, cell and gene therapies, nanomedicine, and digital therapeutics, going well beyond standard drug control as scientific discovery picks up speed. The development, composition, and future course of international drug regulatory regimes are all thoroughly assessed in this research. The structure and importance of DRA are thoroughly explained in the outset, and then important historical occurrences that influenced regulatory policy are examined. To illustrate differences and convergence in global systems, the functions of significant international authorities such as the FDA, EMA, CDSCO, PMDA, MHRA, and TGA are studied. A thorough examination of ICH harmonisation emphasizes how important it is for creating common technical and scientific standards. Global inconsistency, complicated clinical ethics, data integrity issues, fake medications, and regulatory capacity limitations are some of the current issues that are criticized. The research also examines the vital role of international cooperation, including harmonized inspection systems, mutual recognition agreements, and collaborative evaluations. The future scope places a strong emphasis on Blockchain-based supply chains, digital transformation, AI-enabled regulatory evaluations, adaptive trial designs, and the slow transition to unified global frameworks. All things considered, this analysis emphasizes how crucial strong, open, and flexible regulatory frameworks are to safeguarding public health while also promoting innovation and fair access to life-saving medications.
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How To Cite
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IJCRT — journal style
"A REVIEW ON REGULATORY AFFAIRS", IJCRT - International Journal of Creative Research Thoughts (www.ijcrt.org), ISSN:2320-2882, Vol.13, Issue 12, page no.f116-f123, December 2025, Available :https://ijcrt.org/papers/IJCRT2512578.pdf
APA — 7th edition
Chavan, S. R., Kale, D. V., Thakare, D. M., Narwade, M. V., & Chivte, M. V. K. (2025). A REVIEW ON REGULATORY AFFAIRS. International Journal of Creative Research Thoughts, 13(12), f116-f123. https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578
MLA — 9th edition
Chavan, Shubham Rajendra, et al. "A REVIEW ON REGULATORY AFFAIRS." International Journal of Creative Research Thoughts, vol. 13, no. 12, 2025, pp. f116-f123, https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578.
Chicago — 17th, bibliography
Chavan, Shubham Rajendra, et al. "A REVIEW ON REGULATORY AFFAIRS." International Journal of Creative Research Thoughts 13, no. 12 (2025): f116-f123. https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578.
Harvard — author–date
Chavan, S.R. et al. (2025) 'A REVIEW ON REGULATORY AFFAIRS', International Journal of Creative Research Thoughts, 13(12), pp. f116-f123. Available at: https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578
IEEE — numbered reference
S. R. Chavan, D. V. Kale, D. M. Thakare, M. V. Narwade and M. V. K. Chivte, "A REVIEW ON REGULATORY AFFAIRS," IJCRT, vol. 13, no. 12, pp. f116-f123, Dec. 2025.
Vancouver — biomedical
Chavan SR, Kale DV, Thakare DM, Narwade MV, Chivte MVK. A REVIEW ON REGULATORY AFFAIRS. IJCRT. 2025 Dec;13(12):f116-f123.
AMA — 11th edition
Chavan SR, Kale DV, Thakare DM, Narwade MV, Chivte MVK. A REVIEW ON REGULATORY AFFAIRS. IJCRT. 2025;13(12):f116-f123. Accessed at https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578
BibTeX — Zotero, Mendeley, LaTeX
@article{IJCRT2512578,
author = {Shubham Rajendra Chavan and Dr.Vijaykumar Kale and Dr.Mahesh Thakare and Mr.Vaibhav Narwade and Ms.Vaishnavi K. Chivte},
title = {A REVIEW ON REGULATORY AFFAIRS},
journal = {International Journal of Creative Research Thoughts},
volume = {13},
number = {12},
pages = {f116-f123},
year = {2025},
month = {December},
issn = {2320-2882},
url = {https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578}
}
RIS — EndNote, RefWorks
TY - JOUR
AU - Chavan, Shubham Rajendra
AU - Kale, Dr.Vijaykumar
AU - Thakare, Dr.Mahesh
AU - Narwade, Mr.Vaibhav
AU - Chivte, Ms.Vaishnavi K.
TI - A REVIEW ON REGULATORY AFFAIRS
T2 - International Journal of Creative Research Thoughts
JA - IJCRT
VL - 13
IS - 12
PY - 2025
SN - 2320-2882
UR - https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578
SP - f116-f123
ER -
Issue
Volume 13 Issue 12,
December-2025
Pages : f116-f123
Article Information
- Published In
- International Journal of Creative Research Thoughts — Volume 13, Issue 12, December 2025
- Pages
- f116-f123
- Published
- December 2025
- Registration ID
- IJCRT_298915
- Published Paper ID
- IJCRT2512578
- Research Area
- Pharmacy All
- Author Type
- Indian Author
- Location
- Pune, Maharashtra, India
- Peer Review
- Request Peer Review Report
- Licence
- CC BY 4.0 · Open Access
- ISSN & Impact Factor
- 2320-2882 · IF 9.17
- Downloads
- 203
- Permanent Link
- https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512578
- Published Paper PDF
- https://ijcrt.org/papers/IJCRT2512578.pdf
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