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Abstract

This review paper provides a comprehensive analysis of the field of regulatory affairs, offering insights into its historical evolution, current challenges, emerging trends, and future directions. Regulatory affairs play a pivotal role across various industries in ensuring compliance with laws and regulations, maintaining product quality, and safeguarding public health and safety. Drug regulatory affairs are an important part of the pharmaceutical industry. As usual the pharmaceutical industry is growing very fast, and there is a need Regulatory affairs experts to meet current needs industry for global competition. Pharmaceutical drug regulatory affairs covers different registration parameter of pharmaceutical product. Various government agencies are involved in regulating drugs within their market, namely, USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada. Regulatory affairs ensures the Quality, Safety and efficacy of product.

Keywords

Regulatory Affairs, Quality Assurance, Compliance, Regulatory authority, Current challenges

Reference

  1. https://en.wikipedia.org/wiki/Regulatory_affairs.
  2. Kawade D, Sahastrabuddhe M, Dubey M, Gadodiya M, Gore N, Kinkar M, et al. an Overview of Regulatory Affairs in Pharmaceutical industries. J Emerg Technol Innov Res. 2021;8(6):391–408. 
  3. Rahalkar H. Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs. Pharm Regul Aff. 2012;S11(01):1–11. 
  4. Shah D, Mistry M. Regulatory Affairs – an overview. In: pharmatutor. 2012. 
  5. Badjatya JK. Overview of Drug Regulatory Affairs and Regulatory Profession. Int J Drug Regul Aff. 2013;1(1):1–4. 
  6. Praneeth P. Regulatory Affairs and its Role in Pharmaceutical Industry. Int J Pharm Biomed Eng. 20(1):1–2. 
  7. Mallik J. Pharmaceutical Regulatory Affairs Hyderabad International Convention Centre, India 2 nd International Conference and Exhibition on Role of regulatory affairs in the pharmaceutical industry. 2012;1(4):7689. 
  8. Hägglöf I, Holmgren Å. Regulatory affairs. Drug Discov Dev Technol Transit. 2013;285–301. 
  9. Srivastava DA. Country level report on the pharmaceutical sector in India. Report commissioned by DFID, UK. 
  10. Keshari Roshan. Role of Regulatory Affairs in Pharmaceutical Company: an Overview. Glob J Res Anal. 2018;7(1):2277–8160. 
  11. Salve PR, Jadhav VA. Review on drug regulatory affairs and new drug approval process in India. Int J Res Publ Rev. 2022;3(7):1290–1298. 
  12. Mankar SD, Gholap VD, Zende TP, Dighe RS. Drug regulatory agencies in India, USA, Europe, and Japan a review. Int J institutional Pharm life Sci. 2014;4(2):288–297. 
  13. Kale UI, Shinde ND, Bombale PP. Regulatory affairs in pharmaceutical industry. Int J trends Innov. 2023;8(4):1170–1173. 
  14. Sutar MR, Gawhane DR. Study of Drug Regulatory Approval Process and Comparative Requirement of Common Technical Documents (CTD) in Europe, USA and India in Coordination with Drug Developmental Process Monappa. Int J Pharm Sci Rev Res. 2013;20(2):68–79. 
  15. Swetha Sri R, Mounika CH, Bhavya Sri DK, Student R. A Review on Pharamaceutical Regulatory Agencies of India, Usa and Europe. Int J Res Trends Innov. 2020;5(3):2456–3315. 
  16. Dumpala R, Patil C. An overview on regulatory affairs in pharmaceutical industry. Int J Univers Pharm Bio Sci. 2020;9(4):158–168. 
  17. Harhsa YS. Role of regulatory affairs in pharmaceutical industry. Int J Pharm Res Bio-Science. 2017;6(2):170–177. 
  18. Bandgar  priyanka S, Rokade VG, Hingane LD. Review on Regulatory Affairs in Pharmaceutical Indusrties. J Emerg Technol Innov Res. 2020;7(1):66–73. 
  19. Mikhail M. Global regulatory challenges and current hot topics in the regulatory world. Pharm Regul Aff. 2017;06(02):88. 
  20. Chisholm O, Critchley H. Future directions in regulatory affairs. Front Med. 2023;9(January):1–11. 
  21. 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. 
  22. D. Chaudhari D, R. Koli M. Drug Regulatory Affairs: Short Review. Asian J Res Pharm Sci. 2023;13(1):73–6.

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Kishor S. Arote
Corresponding author

Department of Pharmaceutical Quality Assurance, KVPS Institute of Pharmaceutical Education Boradi, Dhule 425428.

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Darshan A. Salade
Co-author

Department of Pharmaceutical Quality Assurance, KVPS Institute of Pharmaceutical Education Boradi, Dhule 425428.

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Nilesh V. Patil
Co-author

Department of Pharmaceutical Quality Assurance, KVPS Institute of Pharmaceutical Education Boradi, Dhule 425428.

Kishor S. Arote*, Darshan A. Salade, Nilesh V. Patil, A Brief Review on Regulatory Affairs: Ensuring Compliance, Safety, and Market Access , Int. J. in Pharm. Sci., 2023, Vol 1, Issue 10, 22-30. https://doi.org/10.5281/zenodo.8397986

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