Drug approval process in US, Europe and India and its regulatory requirements: A Review

  • Krishnasis Chakraborty Al-Ameen College of Pharmacy, bangalore
  • Kavita Yadav
DOI https://doi.org/10.22270/ijdra.v6i3.266

Abstract

Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO) (1).

Keywords: Drug Approval, Regulatory Requirements, USFDA, EMA, CDSCO, DCGI.

Downloads

Download data is not yet available.

References

1. Rick NG. Drugs from discovery to approval. New Jersey: John Wiley & Sons; 2015.
2. IRA R Berry, Robert P Martin, editors. The Pharmaceutical Regulatory Process. 2nd ed. Informa healthcare: 45; 2002 Dec 02.
3. Kuhlmann J. Int. Journal of Clinical Pharmacology and Therapeutics. 1999; 37(12):575-83.
4. Bhatt A. Indian Journal of Pharmacology. 2004; 36(4):207-8.
5. CDER Guidance. A review for OCRA US RAC Study [Internet]. US FDA 2012 [cited 2018 May 25]. Available from:
https://www.fda.gov/cder/regulatory/applications/
6. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Med. J. 2004; 181:293-4.
7. Ed Miseta. What You Need to Know About FDA's Clinical Outcome Assessment Compendium [Internet]. [cited 2018 Jan 06]. Available from:
https://www.clinicalleader.com/doc/what-you-need-to-know-about-fda-s-clinical-outcome-assessment-compendium-
8. U.S. Food and Drug. Law History [Internet]. US FDA; 2005 [cited 2018 Mar 10]. Available from:
https://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.html.
9. Lipsky MS and Sharp LK. J Am Board Fam Pract. 2001; 14:362-7.
10. Jawahar N, Prashob Nair A, Ramachandran. Pharma Times. 2015; 47(1):35-9.
11. Food and Drugs: Chapter I-Food and Drug, Title 21: PART 312- Investigational New Drug Application [Internet]. 2003 [cited 2018 May 11]. Available from:
https://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03
12. Jawahar N, Shrivastava N, Ramachandran, Priyadharshini RB. J. Pharm. Sci. & Res. 2015; 7(4):219-25.
13. U. Nitin Kashyap, Vishal Gupta, H V Raghunandan. J. Pharm. Sci. & Res. 2013; 5(6):131-6.
14. European Commission: The Notice to Applicants; Volume 2A; Procedures for marketing authorization [Internet]. EMEA; 2004 [cited 2018 Mar 15]. Available from:
http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a _chap1_2005- 11
15. EMA. Guideline on non-clinical local tolerance testing of medicinal products [Internet]. EMEA; 2015 [cited 2018 Jan 10]. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/
16. Ghalamkarpour A. Marketing Authorization Procedures in the European Union - Making the Right Choice [Internet]. 2009 Dec [cited 2018 Jun 10]. Available from:
https://www.sgsgroup.fr/~/media/Global/Documents/Technical%20Documents/SGS-Clinical-Marketing-Authorization-EN-09.pdf
17. Regulatory requirements. Timeline for approval [Internet]. 2005 [Cited 2018 Feb 02]. Available from: www.clinpage.com/article/indias_regulation_timeline/C9.
18. Technical Guidance on Development of In vitro Companion Diagnostics and Corresponding therapeutic Products [Internet]. PMDA; 2013 Dec 26 [Cited 2018 Jan 10]. Available from:
https://www.pmda.go.jp/files/000153149.pdf
19. Vishal Gupta N, Mohan Reddy C, Pradeep Reddy K, R Ajay Kulkarni, Shivakumar HG. Process of Approval of New Drug in India with Emphasis on Clinical Trials. International Journal of Pharmaceutical Sciences Review and Research. 2012; 13(2):17-23.
20. Honorio S. Phases of drug development; Good practices in clinical research [Internet]. [cited 2018 May 26]. Available from:
http://www.hstelearning.mit.edu.
21. Ravinder RB, Suresh N. Regulatory stages for New Drug approvals [Internet]. [cited 2018 Jan 07]. Available from:
https:// www.observerindia.com/cms/export/orfonline /modules/occasionalpaper/attachments/Drug_Discovery_ Book_1260179432814.pdf
22. Lachman L, Liberman HA, Kanig JL. The Theory and Practice of Industrial Pharmacy. Varghese Publishing House; 1987.
23. The drug development and approval process Overview of the process [Internet]. 2011 [cited 2018 Mar 03]. Available from:
http://www.mhsource.com/resource/process.html.
Statistics
1667 Views | 3493 Downloads
How to Cite
1.
Chakraborty K, Yadav K. Drug approval process in US, Europe and India and its regulatory requirements: A Review. Int J Drug Reg Affairs [Internet]. 2018Sep.15 [cited 2025Mar.18];6(3):31-9. Available from: https://www.ijdra.com/index.php/journal/article/view/266
Issue
Vol 6 No 3 (2018): VOLUME 6, ISSUE 3, 2018
Section
Review
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.

I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.

Download link for COPYRIGHT FORM