A review on regulatory affairs and regulatory requirements for new drug approval
Abstract
Regulatory affairs in the pharmaceutical industry are essential as the sector grows rapidly; the demand for regulatory affairs experts is increasing. Regulatory affairs professionals to meet the industry's evolving needs in the face of global competition. Regulatory affairs are a profession that serves as the interface between pharmaceutical industries and government authorities worldwide. Developing a new drug is a lengthy process, spanning several years and encompassing discovery, toxicology studies, and clinical trials.Pharmaceutical drug regulatory affairs address the various registration criteria for pharmaceutical products.Due to the desire of Protecting public health worldwide is a top priority. A new profession called pharmacy was created. Developing a new drug is a complex and lengthy process that requires extensive research and development across multiple disciplines, including chemistry, manufacturing, controls, preclinical science, and clinical trials. This article will focus on the drug approval process in three major regions: the United States, Europe, and India.
Keywords:
Regulatory affairs, Discovery, Preclinical
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References
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29. Nagesh Patil, Tanvi Jogalekar Regulatory Affairs: The Gateway Between The Industry And Regulatory Bodies
2. Nighat Razvi, Muneeb Ahmed, Fakhsheena Anjum, Perspective of pharmaceutical regulatory affairs professionals in Pakistan, Journal of Pharmaceutical and Biological Sciences, ISSN: 2320-1924, Volume 3(2): 51-55, 28-06-2015
3. Sachin C Itkar, Dr. Ns Vyawahare, “Drug Regulatory Affairs”, Third edition (2015).
4. “Need For the Introduction of Regulatory Affairs in the Pharmacy Curriculum” Health Administrator Vol: XIX Number 1: 51-52.
5. Douglas J. Pisano and David S. Mantus, Text book of FDA Regulatory Affairs, A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition, August 2008.
6. Hasumati Rahalkar, Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs, Pharmaceutical Regulatory Affairs, Pharmaceutical Regulatory Affairs: Open Access; 2012.
7. Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177; 2017
8. Keshari Roshan JA. January_2018_1515152068__76. 2018;7(1):33-39
9. Bonthagarala B. ROLE OF REGULATORY AFFAIRS IN A PHARMACEUTICAL INDUSTRY[Internet].2017.Availablefrom:https://www.researchgate.net/publication/318816724.
10. Kennedy T. Strategic project management at the project level. Clinical Research and Regulation, 18:345–65, 2001.
11. Anu Gummerus, Marja Airaksinen, Mia Bengtstrom, and Anne Juppo. Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies—Why and What?. Journal of Pharmaceutical Innovation, 11:46–52, 2016.
12. Casey G., Jr. Leading in a “VUCA” world. Fortune. (2014) 169:75–6. [PubMed][Google Schola.
13. The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization. (2021, December 8). QbD Group. https://qbdgroup.com/en/blog/the-key-role-of-regulatoryaffairsinthepharmaceutical-industry-from-drug-development-to-commercialization
14. Regulatory Affairs from Wikipedia, the free encyclopedia modified [online] 7th April. Available from http://en.wikipedia.org/wiki/Regulatory_Affairs
15. Drago D, Yap M. Regulatory OE-CRand, undefined. Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners. Taylor Fr [Internet]. 2016.
16. Kontoghiorghe, C.N.; Andreou, N.; Constantinou, K.; Kontoghiorghes, G.J. World health dilemmas: Orphan and rare diseases,orphan drugs and orphan patients. World J. Methodol. 2014, 4, 163–188.
17. International regulatory affair updates 2005 available at http://www.iraup.com/about.php
18. Chisholm O, Critchley H. Future directions in regulatory affairs. Front Med. 2023;9(January):1–11.
19. Drashti P, Kothari CS, Shantanu S, Manan S. In-depth review on ‘innovation and regulatory challenges of the drug delivering medical devices.’ J Generic Med. 2019;15(1):18–28.
20. Mr. Rajesh Dumpala , Mr. Chirag Patil Research Scientist, Dept. F&D-(MS&T) Alembic Research Centre, Vadodara, Gujarat, India. Research Associate, Dept. F&D- (MS&T) Alembic Research Centre, Vadodara, Gujarat, India. International Journal of Universal Pharmacy and Bio Sciences.
21. http://ijdra.com/index.php/journal/article/vie w/401 Aishwarya Patil* and Anjali Thakre Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune
22. https://blog.montrium.com/blog/how-tosuccessfullyprepare-for-the-upcoming-fdaectd-deadlines [Accessed on 13 Oct 2022].
23. Nagesh Patil, Tanvi Jogalekar Regulatory Affairs: The Gateway Between The Industry And Regulatory Bodies Pharmaceutical Resonance 2023 Vol. V - Issue II
24. .P. Praneeth. Regulatory Affairs and its role in Pharmaceutical Industry. International Journal of Pharmacy and Biomedical Engineering (SSRG-IJPBE). Jan-Feb, 2016; 3(1):
25. DolitaShah*, Mayur Mistry. Pharma tutor. https://www.pharmatutor.org/articles/anoverview-of-regulatory-affairs-and-its-importance-in-pharmaceuticals-other-industries. of drug regulatory affairs in Pharma Industry. World Journal of Pharmaceutical Research SJIF.,2015: 4(6):615-625.
26. Badhe P, Wagh T, Shirapure K. A review on role of regulatory affairs in pharmaceutical industry.
27. Chandra, A. and Kumar, B., 2016. A comparitive study of the drug approval process in USA, India, Japan And Europe. World journal of pharmaceutical Research, 6 (1), pp.311-322.
28. Kumar, B., 2013. Overview of Drug Regulatory Affairs and Regulatory Profession.
29. Nagesh Patil, Tanvi Jogalekar Regulatory Affairs: The Gateway Between The Industry And Regulatory Bodies
Published
31/12/2024
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How to Cite
Sireesha, B., H. S, L. T. S, N. p, and V. S. V. L. U. “A Review on Regulatory Affairs and Regulatory Requirements for New Drug Approval”. International Journal of Health Care and Biological Sciences, Vol. 5, no. 4, Dec. 2024, pp. 22-28, doi:10.46795/ijhcbs.v5i4.643.
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