ABSTRACT:
Clinical trials serve as the cornerstone for advancing medical knowledge, ensuring patient safety, and enabling the approval of new therapies across the globe. However, the regulatory frameworks governing clinical trials vary significantly across regions, reflecting differences in healthcare systems, legal requirements, and regulatory authorities. This article provides an overview of clinical trials and the clinical trial application (CTA) process from a regulatory perspective in Europe, the United States, and India. It highlights the role of key regulatory bodies such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Central Drugs Standard Control Organization (CDSCO), and compares the processes, timelines, and documentation requirements across these jurisdictions. By examining both the similarities and unique aspects of each system, the article aims to provide a comprehensive understanding of the global clinical trial landscape and its implications for drug development and approval.
Cite this article:
Akshatha, Chandan B.V. Regulatory Overview: Clinical Trial Application Process in Europe, USA and India. IJRPAS, August 2025; 4 (8): 40-64.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.4804
1.
Make, B.
(2007). How Can We Assess Outcomes of Clinical Trials: The MCID Approach. COPD:
Journal of Chronic Obstructive Pulmonary Disease, 4(3), 191–194. https://doi.org/10.1080/15412550701471231
2.
Bhatt,
Arun. Evolution of Clinical Research: A History Before and Beyond James Lind.
Perspectives in Clinical Research 1(1):p 6-10, Jan–Mar 2010.
3.
Kim WO. Institutional review board (IRB)
and ethical issues in clinical research. Korean J Anesthesiol. 2012 Jan
1;62(1):3.
4.
Nuremberg Trials [Internet].
Newspapers.com; [cited 2025 Aug 10]. Available from: https://www.newspapers.com/topics/world-war2/nuremberg-trials/
5.
Selvarajan S, Behera S, Anandabaskar N, Das S, Xavier
A. Indian Council of Medical Research’s National Ethical Guidelines for
biomedical and health research involving human participants: The way forward
from 2006 to 2017. Perspect Clin Res. 2019 Jan 1;10(3):108.
6.
Adams-Spink G. The real story behind a great
thalidomide medical disaster [Internet]. www.standard.co.uk. 2018. Available
from: https://www.standard.co.uk/culture/books/the-thalidomide-catastrophe-by-martin-johnson-raymond-g-stokes-and-tobias-arndt-review-a3880221.html
7.
Britannica. Tuskegee syphilis study | American history.
In: Encyclopædia Britannica [Internet]. 2019. Available from: https://www.britannica.com/event/Tuskegee-syphilis-study
8.
Elliott D. In Tuskegee, Painful History Shadows Efforts
To Vaccinate African Americans [Internet]. NPR.org. NPR; 2021. Available from: https://www.npr.org/2021/02/16/967011614/in-tuskegee-painful-history-shadows-efforts-to-vaccinate-african-americans
9.
Yip C, Han NLR, Sng BL. Legal and
ethical issues in research. Indian J Anaesth. 2016 Sept 1;60(9):684.
10. Nordentoft
HM, Kappel N. Vulnerable participants in health research: methodological and
ethical challenges. Journal of Social Work Practice. 2011 Sept 1;25(3):365–376.
11. Tracer.
Early phase clinical trials | Fastest in-patient | TRACER [Internet]. TRACER.
2024. Available from: https://www.tracercro.com/early-phase-clinical-trials/
12. Rohilla A, Singh RK, Sharma D, Keshari
R, Kushnoor A. Phases of clinical trials: a review. International Journal of
Pharmaceutical, Chemical & Biological Sciences. 2013 Jul 1;3(3).
13. Samala VR, Venkatesh P. Phases of
clinical trials: a review. Asian Journal of Hospital Pharmacy. 2022 Jan
24:09-13.
14. https://euclinicaltrials.eu/about-this-website/#transition-period
15. https://www.clinicalleader.com/doc/understanding-the-basics-of-eu-clinical-trials-with-ctis-0001
16. https://www.ema.europa.eu/en/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-initial-application-additional-member-state-concerned-substantial-modification-non-substantial-modification_en.xlsx
17. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation
18. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:02001L0020-20090807
19.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/information-sponsor-investigators-submitting-investigational-new-drug-applications-inds
20.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview
21.
https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
22.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents
23.
https://www.cc.nih.gov/orcs/ind/what-is-an-ind
24.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-regulatory-and-administrative-components
25.
https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/clinical-trials/
26.
https://cliniexperts.com/india-regulatory-services/drug/for-manufacturer/investigational-new-drug-ind/
27.
https://cdscoonline.gov.in/CDSCO/homepage
28.
Chrome
extension://efaidnbmnnnibpcajpcglclefindmkaj/https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Checklist/Update_Checklist_10July2018.pdf
29.
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/Approval_process_flowchart_GCT_Online.pdf
30. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/GCT_Checklist.pdf