ISSN2320-2882
Impact Factor9.17
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ESTD2013
Peer ReviewTransparent
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Paper Title
REPORT ON DRUG REGULATORY AFFAIRS
Authors
Mr. Vaibhav Narwade , Ms. Snehal Somnath Shinde , Dr. VijayKumar Kale , Dr. Mahesh Thakare
Keywords
Drug Regulatory Affairs, USFDA, EMA, CDSCO, ICH Guidelines, Biosimilars, Generics, Pharmacovigilance, Clinical Trials, Regulatory Pathways, CTD, NDA, ANDA, Drug Approval.
Abstract
Drug Regulatory Affairs (DRA) is essential to guaranteeing their effectiveness, safety, and quality. Drug regulation must change to accommodate new technologies like biotechnology, nanomedicine, gene therapy, and biosimilars as the pharmaceutical industry changes due to quick scientific breakthroughs. The USFDA, EMA, CDSCO, MHRA, PMDA, and TGA are just a few of the key regulators that are highlighted in this thorough review of the world's drug regulatory systems. Additionally, it looks at how the International Council for Harmonisation (ICH) has contributed to regulatory convergence by establishing uniform standards for efficacy, safety, and quality. The paper also goes into detail on different drug approval regulatory paths, including IND, NDA, ANDA, BLA, biosimilar approvals, fast-track authorizations, and emergency use authorizations. Special focus is paid to generic medications, biosimilars, and interchangeability principles, which greatly affect healthcare affordability and accessibility. The issues encountered by regulatory authorities--such as rising complexity of clinical trials, worldwide harmonization gaps, ethical concerns, and delays in approvals--are critically reviewed. The report delves deeper into the future of drug regulation, forecasting a move towards Blockchain-enabled supply chain monitoring, digital regulatory systems, AI-assisted assessments, and adaptive clinical trial designs. In general, the study highlights how crucial robust regulatory regimes are for advancing public health, fostering innovation, and guaranteeing that everyone has access to safe and effective medications.
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How To Cite
Choose the style your journal or department asks for, then copy it. Every version below is generated from this paper's own record.
IJCRT — journal style
"REPORT ON DRUG REGULATORY AFFAIRS", IJCRT - International Journal of Creative Research Thoughts (www.ijcrt.org), ISSN:2320-2882, Vol.13, Issue 12, page no.g122-g129, December 2025, Available :https://ijcrt.org/papers/IJCRT2512682.pdf
APA — 7th edition
Narwade, V., Shinde, S. S., Kale, V., & Thakare, M. (2025). REPORT ON DRUG REGULATORY AFFAIRS. International Journal of Creative Research Thoughts, 13(12), g122-g129. https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512682
MLA — 9th edition
Narwade, Vaibhav, et al. "REPORT ON DRUG REGULATORY AFFAIRS." International Journal of Creative Research Thoughts, vol. 13, no. 12, 2025, pp. g122-g129, https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512682.
Chicago — 17th, bibliography
Narwade, Vaibhav, et al. "REPORT ON DRUG REGULATORY AFFAIRS." International Journal of Creative Research Thoughts 13, no. 12 (2025): g122-g129. https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512682.
Harvard — author–date
Narwade, V. et al. (2025) 'REPORT ON DRUG REGULATORY AFFAIRS', International Journal of Creative Research Thoughts, 13(12), pp. g122-g129. Available at: https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512682
IEEE — numbered reference
V. Narwade, S. S. Shinde, V. Kale and M. Thakare, "REPORT ON DRUG REGULATORY AFFAIRS," IJCRT, vol. 13, no. 12, pp. g122-g129, Dec. 2025.
Vancouver — biomedical
Narwade V, Shinde SS, Kale V, Thakare M. REPORT ON DRUG REGULATORY AFFAIRS. IJCRT. 2025 Dec;13(12):g122-g129.
AMA — 11th edition
Narwade V, Shinde SS, Kale V, Thakare M. REPORT ON DRUG REGULATORY AFFAIRS. IJCRT. 2025;13(12):g122-g129. Accessed at https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512682
BibTeX — Zotero, Mendeley, LaTeX
@article{IJCRT2512682,
author = {Vaibhav Narwade and Snehal Somnath Shinde and VijayKumar Kale and Mahesh Thakare},
title = {REPORT ON DRUG REGULATORY AFFAIRS},
journal = {International Journal of Creative Research Thoughts},
volume = {13},
number = {12},
pages = {g122-g129},
year = {2025},
month = {December},
issn = {2320-2882},
url = {https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512682}
}
RIS — EndNote, RefWorks
TY - JOUR
AU - Narwade, Vaibhav
AU - Shinde, Snehal Somnath
AU - Kale, VijayKumar
AU - Thakare, Mahesh
TI - REPORT ON DRUG 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=IJCRT2512682
SP - g122-g129
ER -
Issue
Volume 13 Issue 12,
December-2025
Pages : g122-g129
Article Information
- Published In
- International Journal of Creative Research Thoughts — Volume 13, Issue 12, December 2025
- Pages
- g122-g129
- Published
- December 2025
- Registration ID
- IJCRT_299190
- Published Paper ID
- IJCRT2512682
- Research Area
- Science and Technology
- Author Type
- Indian Author
- Location
- India
- Peer Review
- Request Peer Review Report
- Licence
- CC BY 4.0 · Open Access
- ISSN & Impact Factor
- 2320-2882 · IF 9.17
- Downloads
- 193
- Permanent Link
- https://ijcrt.org/viewpaperforall.php?paper=IJCRT2512682
- Published Paper PDF
- https://ijcrt.org/papers/IJCRT2512682.pdf
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International Journal of Creative Research Thoughts
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The authors would like to thank the reviewers and the editorial board of International Journal of Creative Research Thoughts for their careful reading and constructive comments, and all colleagues who supported the preparation of this manuscript.
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