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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)
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ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013
Call For Paper - Volume 14 | Issue 8 | Month- August 2026
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Published Paper Details:
Paper Title
Understanding Regulation For The Traditional Medicine USFDA & CDSO Regulatory Countries
Authors
Miss.Shradhda Hemraj Badole, Mr. Chetan T. Choudhary
Keywords
Regulatory Affairs, Investigational New Drug (IND), New Drug Application (NDA), Drug Approval, CDSCO, FDA, Clinical Trials, Post-Marketing Surveillance, Drug Development, Regulatory Compliance.
Abstract
Regulatory affairs ensures the safety, quality, and efficacy of pharmaceutical products by managing regulatory submissions and compliance throughout drug development. It plays a vital role in obtaining approval for Investigational New Drug (IND) and New Drug Application (NDA) submissions before marketing. Regulatory professionals coordinate clinical and nonclinical studies while ensuring adherence to national and international guidelines. In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for approving new drugs. This review outlines the regulatory process for new drug approval, required documentation, and the importance of post-marketing surveillance (Phase IV), while comparing regulatory frameworks with global authorities such as the FDA.
IJCRT's Publication Details
Unique Identification Number - IJCRT21X0413
Paper ID - 310949
Page Number(s) - x436-x486
Pubished in - Volume 14 | Issue 6 | June 2026
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Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882
E-ISSN Number - 2320-2882
Cite this article
Miss.Shradhda Hemraj Badole, Mr. Chetan T. Choudhary, "Understanding Regulation For The Traditional Medicine USFDA & CDSO Regulatory Countries", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.14, Issue 6, pp.x436-x486, June 2026, Available at :http://www.ijcrt.org/papers/IJCRT21X0413.pdf
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Volume 14 | Issue 8
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Volume 14 | Issue 8
Last Date :
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Submit Manuscript Online Impact Factor: 7.97 Review Results : Within 02-03 Days Paper Publication : Within 02-03 Days
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ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
ISSN and 7.97 Impact Factor Details
ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
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