Regulatory requirements for the New Drug approval process in different Countries
Abstract
Currently, different nations must adhere to various regulatory standards in order to get a new drug's marketing authorization application (MAA) approved. The US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Central Drug Standard Control Organization (CDSCO), the Therapeutic Goods Administration (TGA) in Australia, the State Food and Drug Administration (SFDA) in China, and the Therapeutic Products Directorate (TPD) in Canada were all studied for this production's regulatory requirements and drug approval process.
Keywords:
Drug Regulatory affairs, NDA, USFDA, EMA, CDSCO, New Drug Approval Process, FDA, Marketing authorization applications (MAA)
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References
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doi: 10.20959/wjpr20187-11267
2. Salunke SK, Shinde SS. A Review on Regulatory Affairs. International Journal of Research Publication and Reviews. 2022 June; 3(6):4536-4545.
3. Shah C, Dave P. Regulatory Approval in India: An updated review. Applied clinical trials; 2016 May 04.
4. Singh PM, Pahwa S, Chaudhary S & Sethi VA. New Drug Approval Procedure in Different Countries: A Review. International Journal of ChemTech Research. 2017;10(12):01-21.
5. Kataria BC, Panchal PJ, Panchasara AK, Pandya AS, Parmar MR. Comparison of new drug approval by regulatory agencies of US, EU and India. International Journal of Basic & Clinical Pharmacology. 2016 Feb;5(1):112-115.
doi:http://dx.doi.org/10.18203/2319-2003.ijbcp20160110.
6. Jawahar N, Vidhya Lakshmi T. Regulatory Requirements for the Drug Approval Process in the US, Europe, and India. Journal of Pharmaceutical Science and Research. 2017;9(10):1943-1952.
7. Sawant AM, Mali DP and Bhagwat DA. Regulatory Requirements and Drug Approval Process in India, Europe and US. Pharmaceutical Regulatory Affairs 2018 Dec;7(2).
doi: 10.4172/2167-7689.1000210
8. Pisano DJ, David M. Overview of Drug Development, and the FDA. In: Pisano DJ, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics. Florida: CRC Press LLC; 2004; 2-20.
9. Ali A, Ali J, Sahni JK, Qureshi J. United States of America. In: International Licensing. New Delhi: Hamdard University, Excel Books Pvt Ltd; 2007.p. 51-110.
10. Randall B IV. The U.S. Drug Approval Process: A Primer; Congressional Research Service; The Library of Congress; 2001Jun 01.
11. William RP, Raymond DM. Drug Regulatory Affairs. In: Lachman L, Lieberman HA, The theory, and practice of Industrial Pharmacy. India: CBS Publishers and Distributors; 2009.p. 856-82.
12. Peck GE, Poust R. Food and Drug Laws that affect Drug Product Design, Manufacture, and Distribution. In: Gilbert SB, Christopher TR, Modern Pharmaceutics. 4th ed. New York: Marcel Dekker Inc; 2002.p. 930-46.
13. Food and Drug Administration. Investigational New Drug Application. [Internet].FDA; 2013 Nov 02 [cited 2023 Jan 15]. Available from:
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/
14. Rick NG. Drugs from discovery to approval. 2nd ed. John Wiley & Sons, Inc.; 2008.p.201- 202
15. IRA RB, Robert PM. The Pharmaceutical Regulatory Process. 2nd ed. Informa Healthcare; 2008.p. 45
16. Rick NG. Drugs from discovery to approval. 2nd ed. John Wiley & Sons, Inc.; 2008.p. 203- 210.
17. Prajapati V, Goswami R, Makvana P, Badjatya JK. A Review on Drug Approval Process for US, Europe and India. Int J Drug Reg Affairs [Internet]. 2014Mar.6 [cited 2023Jan.01];2(1):1-11. Available from:
https://ijdra.com/index.php/journal/article/view/7.
18. Rick NG. Drugs from discovery to approval. 2nd ed. John Wiley & Sons, Inc., (Hoboken, New Jersey);2008 Apr.p. 215-217
19. Mahapatra AK, Sameeraja NH and Murthy PN. Drug Approval Process – In United States of America, European Union, and India: A Review. Bentham Science Publishers. 2014;1(1):13-22.
doi: 10.2174/2213476X01666140123234357
20. European Commission. The Rules governing Medicinal Products in the European Community; Volume 2A; Chapter 1; Marketing Authorisation; [Internet]. European Commission; 2013 Jun[cited 2023 Jan 05]. Available from:
http://ec.europa.eu/health/files/EudraLex/vol-2/a/vol2a_chap1_2013-06_en.pdf.
21. Regulatory requirements. Timeline for approval [Internet]. 2005 [cited 2023 Jan 15]. Available from:
www.clinpage.com/article/indias_regulation_timeline /C9.
22. Technical Guidance on the Development of In-vitro Companion Diagnostics and Corresponding therapeutic Products [Internet]. PMDA; 2013 Dec 26 [cited 2023 Jan 15]. Available from:
https://www.pmda.go.jp/files/000153149.pdf
23. Bolar H, Bhatt A. India. In: Chambers AA, International Pharmaceutical Registration. Florida: CRC Press LLC. 2000.p.193-203.
24. Bolar H, Bhatt A. India. In: Chambers AA, International Pharmaceutical Registration. Florida: CRC Press LLC. 2000.p.193-203.
25. Bhatt A. Clinical trials in India: Pangs of globalization. Indian J Pharmacol [serial online] 2004 [cited 2023 Jan 15];36:207-8. Available from:
https://www.ijp-online.com/text.asp?2004/36/4/207/11143
26. Schedule Y. Amendment Version 2005, Drugs and Cosmetics Rules. 1945.p.503-47.
27. Bhatt A. Registration of clinical trials: An idea whose time has come. Ind J Pharmocol. 2008;40(2):47-8.
DOI: 10.4103/0253-7613.41037
28. Gupta N V, Reddy RC, Reddy PK, Kulkarni RA, 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.
29. Honorio S. Phases of drug development; Good practices in clinical research; 2018 May 26. Available from:
http://www.hstelearning.mit.edu.
30. Lachman L, Liberman HA, Kanig JL. The Theory and Practice of Industrial Pharmacy. Varghese Publishing House; 1987.
31. Van Norman G, et al. Drugs, Devices, and the FDA: Part 1. J Am Coll Cardiol Basic Trans Science. 2016 Apr;1(3):170-179.
https://doi.org/10.1016/j.jacbts.2016.03.002
32. Mulaje S.S., Birajdar S.M., Patil B.R., Bhusnure O.G. Procedure for drug approval in different countries: a review. Journal of Drug Delivery & Therapeutics. 2013;3(2):233-238.
33. Deng R. and Kaitin K.I. The Regulation and Approval of New Drugs in China. Drug Information Journal. 2004;37:29-39.
34. Zhen L.H. The drug registration application. Journal of Pharmacy & Pharmaceutical Sciences. 2003; 6(2):211-214
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How to Cite
C., S. “Regulatory Requirements for the New Drug Approval Process in Different Countries”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 1-16, doi:10.22270/ijdra.v11i2.574.
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