A Review on various aspects of Regulatory Affairs

  • Swaranjali Pore Adarsh College of Pharmacy, Shivaji University Kolhapur, near MIDC Khambale, Vita 415311, Maharashtra, India
  • Jeevan Deshmukh Student
  • Shivani Biskite
  • Snehal Jadhav
  • Akshata Moharekar
  • Ankita Gurav


In order to guarantee the efficacy, safety, and calibre of medications, medical equipment, and other healthcare supplies, Regulatory Affairs is essential. Anticipating future trends and difficulties in Regulatory Affairs is crucial as the healthcare sector changes due to technological breakthroughs, globalization, and new regulatory paradigms. This abstract examines the consequences of developing fields for regulatory frameworks, including gene treatments, digital health, artificial intelligence, and personalized medicine. It also covers the increased significance of real-world evidence, patient-centric approaches, and international harmonization in regulatory decision-making. In addition, it looks at the difficulties presented by supply chain interruptions, cybersecurity risks, and regulatory divergence in a world that is changing quickly. Stakeholders may effectively navigate the complicated regulatory landscape of the future by embracing innovation, collaboration, and adaptive regulatory methods facilitate the timely delivery of safe and effective healthcare products to patients worldwide.

Keywords: Efficacy, Regulatory Affairs, Globalization, Artificial Intelligence, Stakeholder, Innovation


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1. Kumar S, Panwar R, et al, Regulatory Affairs in the pharmacy curriculum. International Journal of Research and Development in Pharmacy and Life Sciences. 2013 Oct;2(6):690-8.
2. Vanaja K, Shobha Rani RH. Design of experiments: concept and applications of Plackett Burman design. Clinical research and Regulatory Affairs. 2007 Jan 1;24(1):1-23.
DOI: 10.1080/10601330701220520
3. Rives S, Maude SL, et al, S112: tisagenlecleucel in pediatric and young adult patients (PTS) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): final analyses from the Eliana Study. HemaSphere. 2022 Jun 1;6:13-4.
DOI: 10.1097/01.HS9.0000843344.19780.98
4. Claro RA, Spillman D, et al, global collaborative review program. Clinical Cancer Research. 2020 Dec 15;26(24):6412-6.
DOI: 10.1158/1078-0432.ccr-20-3292
5. Woo M. An AI boost for clinical trials. Nature. 2019 Sep 1;573(7775):S100-. DP10.1038/d41586-019-02871-3
6. Rahalkar H, Sheppard A, et al, Comparison of BRICS-TM countries' biosimilar regulatory frameworks with Australia, Canada and Switzerland: benchmarking best practices. Frontiers in pharmacology. 2021 August, 9;12:711361. DOI: 10.3389/fphar.2021.711361
7. Raghavan A, Demircioglu MA et al, . COVID-19 and the new normal of organizations and employees: an overview. Sustainability.2021 Oct 28;13(21):11942.
DOI:: 10.3390/su132111942
8. Wood KL. The medical dictionary for drug Regulatory Affairs (MEDDRA) project. Pharmacoepidemiology and drug safety. 1994 Jan;3(1):7-13.
DOI:: 10.1002/pds.2630030105
9. Chisholm O, Critchley H. Future directions in Regulatory Affairs. Frontiers in Medicine. 2023 Jan 9;9:1082384.
DOI:: 10.3389/fmed.2022.1082384
10. Shaw B, Chisholm O. Australia's National Medicines Policy is outdated and in need of review. Medical Journal of Australia. 2019 Sep;211(6):252-4.
DOI: 10.5694/mja2.50268
11. Mayes T, De Freitas S. Learning and e-learning: the role of theory. InRethinking pedagogyfor digital age; 2007 Apr 19 p.33-45
DOI: 10.4324/9780203961681
12. Candelon F, Gupta A, Krayer L, Zhukov L. The CEO’s Guide to the Generative AI Revolution; May. 2023.
DOI: 10.3389%2Ffmed.2022.1082384
13. Shaw B, et al, Australia's National Medicines Policy is outdated and in need of review. Medical Journal of Australia. 2019 Sep; 211(6):252-4.
DOI: 10.3389%2Ffmed.2022.1082384
14. Chisholm O. Curriculum transformation: from didactic to competency-based programs in pharmaceutical medicine. Frontiers in Pharmacology.2019 Mar 21;10:438842.
DOI: 10.3389/fphar.2019.00278
15. Shaw B, Chisholm O. Australia's National Medicines Policy is outdated and in need of review. Medical Journal of Australia. 2019 Sep;211(6):252-4.
DOI: 10.5694/mja2.50268
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How to Cite
Pore, S., Jeevan Deshmukh, S. Biskite, S. Jadhav, A. Moharekar, and A. Gurav. “A Review on Various Aspects of Regulatory Affairs”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 2, June 2024, pp. 15-22, doi:10.22270/ijdra.v12i2.664.