Navigating the Regulatory Landscape: Key Trends Shaping Today's Regulatory Affairs Environment
Abstract
Regulatory Science, positioned at the intersection of Science, policy, and law, is essential for safeguarding public health and ensuring the safety and effectiveness of products and practices. It spans various sectors, including pharmaceuticals, medical devices, food and agriculture, environmental protection, and emerging technologies. It faces challenges and opportunities such as rapid technological advancements, global market globalization, and complex scientific discoveries.
This review paper examines current trends and future directions in Regulatory Aspects within the Pharmaceutical World. It explores how regulatory authorities address challenges and delves into the historical development of pharmaceutical regulation globally. The paper also explores innovative approaches and technologies influencing the regulatory processes, investigates future directions in regulation, and proposes recommendations for the future of pharmaceutical regulations.
In conclusion, regulatory Science, with its rich history, holds promise for a bright future. Adapting to technological advancements, embracing collaborative approaches, and investing in research and education are crucial for navigating the complexities of the modern world. Regulatory Science will continue to play a vital role in safeguarding public health and fostering innovation.
Keywords:
Regulatory Science, public health, pharmaceutical regulation, Regulatory landscape, Emerging trends, Collaborative approaches, Innovation in Regulatory Science, Artificial intelligence (AI) in regulatory processes
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References
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35. Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, Califf RM. Real-world evidence—what is it and what can it tell us. N Engl J Med. 2016;375(23):2293-2297.
36. Booth CM, Karim S, Mackillop WJ. Real-world data: towards achieving the achievable in cancer care. Nat Rev Clin Oncol. 2019;16(5):312-325.
37. Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol. 2005;58(4):323-337.
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39. Balani P. Iqvia. [Internet]. informa; 2023 Nov 27 [cited 2023 Nov 3]. Available from:
https://turtlmedia.informa.com/story/future-global-pharmaceutical-regulatory-affairs-industry/page/4/1
40. Ribeiro L, Araújo M, Neves J. A review on the use of artificial intelligence in regulatory compliance. In Advances in Intelligent Systems and Computing. 2019; 952:489-498.
41. Wainberg M, et al. Deep learning in drug discovery. Mol Pharm. 2018;15(11):5346-5355.
42. Hazell A, et al. Use of natural language processing in drug development: A systematic review. J Biomed Inform. 2019;95:103208.
43. Jung K, et al. Quality control in pharmaceutical industry: A review. Pharmaceutics. 2021;13(1):16.
44. Li X, et al. Regulatory intelligence and application of natural language processing in drug safety. Drug Saf. 2019;42(2):159-169.
45. Food and Drug Administration (US). 2021. Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program [Internet]. FDA; 2023 May 15 Available from: https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program
46. Hosny A, Parmar C, Quackenbush J, Schwartz LH, Aerts HJ. Artificial intelligence in radiology. Nat Rev Cancer. 2018;18(8):500-510.
47. Thakkar S, Slikker Jr W, Yiannas F, Silva P, Blais B, Chng KR, Tong W. Artificial intelligence and real-world data for drug and food safety–A regulatory science perspective. Regul Toxicol Pharmacol. 2023;140:105388.
48. Cauchon NS, Oghamian S, Hassanpour S, Abernathy M. Innovation in chemistry, manufacturing, and controls-a regulatory perspective from industry. J Pharm Sci. 2019;108(7):2207-2237.
49. Gutierrez L, Cauchon N, Christian T, Giffin M, Abernathy M. The confluence of innovation in therapeutics and regulation: recent CMC considerations. J Pharm Sci. 2020;109:3524–34. doi: 10.1016/j.xphs.2020.09.025.
50. Boisseau P, Loubaton B. Nanomedicine, Nanotechnology in medicine. C R Hebd Seances Acad Sci. 2011;12(7):620-636.
51. Guidance D. Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; 2011.
52. Resnik DB, Tinkle SS. Ethical issues in clinical trials involving nanomedicine. Contemp Clin Trials. 2007; 28(4):433-441.
53. Guidance D. Considering whether an FDA-regulated product involves the application of nanotechnology. FDA; 2011.
54. Schneider CK, Kalinke U. Toward biosimilar monoclonal antibodies - regulatory and scientific considerations. N Engl J Med. 2017;376(11):1101–1103.
doi: 10.1056/NEJMp1700786.
55. US Food and Drug Administration (FDA). Personalized Medicine in Oncology: Companion Diagnostics. 2018. [Internet]. FDA [cited 2023 Nov 3]. Available from:
https://www.fda.gov/media/110246/download
56. Salmikangas P, Flory E, Reinhardt J. Regulatory challenges for advanced therapy medicinal products. Nat Rev Drug Discov. 2014;13(7):483–484. doi: 10.1038/nrd4344.
57. Woo JH, Kim EC, Kim SM. The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software. Expert Rev Med Devices. 2022;19(3):213-228.
58. Luxi N, Giovanazzi A, Arcolaci A, Bonadonna P, Crivellaro MA, Cutroneo PM, Trifirò G. Allergic reactions to COVID-19 vaccines: risk factors, frequency, mechanisms and management. BioDrugs. 2022;36(4):443-458.
59. European Medicines Agency (EMA). Questions and Answers on 3D Printing of Medicinal Products [Internet]. EMA; 2020 [cited 2023 Nov 3]. Available from:
https://www.ema.europa.eu/en/documents/other/questions-answers-3d-printing-medicinal-products_en.pdf.
60. Lam J, Kwee BJ, Ricles LM, Sung KE. Development of additive manufacturing-based medical products for clinical translation and marketing. In: Bone Tissue Engineering: Bench to Bedside Using 3D Printing. Cham: Springer International Publishing; 2022.p.267-292.
61. National Academies of Sciences, Engineering, and Medicine. Regulating medicines in a globalized world: the need for increased reliance among regulators; 2020.
62. Bolislis WR, De Lucia ML, Dolz F, Mo R, Nagaoka M, Rodriguez H, Kühler TC. Regulatory agilities in the time of covid-19: overview, trends, and opportunities. Clin Ther. 2021;43(1):124-139.
2. Francis JG. The politics of regulation: a comparative perspective. Oxford: Blackwell; 1993:105.
3. Callréus T, Schneider CK. The emergence of regulatory Science in pharmaceutical medicine. Pharmaceutical Medicine. 2013;27:345-351.
4. Callréus T. The precautionary principle and pharmaceutical risk management. Drug Safety. 2005;28:465-471.
5. European Medicines Agency. Draft guideline on similar biological medicinal products 2003; CHMP/437/04Rev1. [Internet]. EMA; 2013 [cited 2023 Nov 3]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978
6. Molins R. Regulatory Science and Regulatory Affairs. Journal of Regulatory Science. 2017;5(2):Editorials.
7. Uyama Y. The importance of a regulatory science approach for better pharmaceutical regulation. Translational and Regulatory Sciences. 2019;1(1):8-11.
8. Kawade D, Sahastrabuddhe M, Dubey M, et al. An overview of regulatory affairs in pharmaceutical industries. Journal of Emerging Technologies and Innovative Research (JETIR). 2021;8(6).
9. Rägo L, Santoso B. Drug regulation: history, present and future. In: International Textbook of Clinical Pharmacology. 2008;2:65-77.
10. Worthen DB. Pharmaceutical legislation: a historical perspective. International Journal of Pharmaceutical Compounding. 2006;10(1):20.
11. Coleman TS. Early Development in the Regulation of Biologics. JSTOR. 2016;71(4).
12. Ballentine CS. Sulfanilamide disaster. FDA Consumer Magazine. 1981;5.
13. Reilly G. The FDA and Plan B: The Legislative History of the Durham-Humphrey Amendments and the Consideration of Social Harms in the Rx-OTC Switch. 2006. Available from: https://dash.harvard.edu/bitstream/handle/1/8965550/Reilly06.html
14. Meadows M. Promoting safe and effective drugs for 100 years. FDA Consumer Magazine. 2006;40(1).
15. Rahalkar H. Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs. Pharmaceutical Regulatory Affairs: Open Access. 2012; S11-002.
doi: 10.4172/2167-7689.S11-0.
16. Zoon KC, Yetter RA. The Regulation of Drugs and Biological Products by the Food and Drug Administration. In: Principles and Practice of Clinical Research. 2012;79-90.
17. Artuso F, Guijt I. Global Megatrends: Mapping the forces that affect us all; 2020.
18. Naughtin C, Hajkowicz S, Schleiger E, Bratanova A, Cameron A, Zamin T, Dutta A. Our future world: Global megatrends impacting the way we live over coming decades; 2022.
19. Zhang D, Mishra S, Brynjolfsson E, Etchemendy J, Ganguli D, Grosz B, Perrault R. The AI index 2021 annual report. arXiv preprint arXiv:2103.06312.
20. Chen RJ, Lu MY, Chen TY, Williamson DF, Mahmood F. Synthetic data in machine learning for medicine and healthcare. Nature Biomedical Engineering. 2021;5(6):493-497.
21. EC. Europe fit for the digital age: Commission proposes new rules and actions for excellence and trust in artificial intelligence. Brussels, Belgium: European Commission; 2021.
22. Suddendorf T, Busby J. Making decisions with the future in mind: Developmental and comparative identification of mental time travel. Learning and Motivation. 2005; 36(2):110-125.
23. Marinus R, Mofid S, Mpandzou M, Kühler TC. Rolling reviews during COVID-19: the European Union experience in a global context. Clinical Therapeutics. 2022;44(3):352-363.
24. Liu F, Panagiotakos D. Real-world data: a brief review of the methods, applications, challenges and opportunities. BMC Medical Research Methodology. 2022;22(1):287.
25. Dagenais S, Russo L, Madsen A, Webster J, Becnel L. Use of real‐world evidence to drive drug development strategy and inform clinical trial design. Clinical Pharmacology & Therapeutics. 2022;111(1):77-89.
26. Riskin D. How real-world evidence is shaping the future of healthcare [Internet]. Forbes; 2021 [cited 2023 Nov 3]. Available from:
https://www.forbes.com/sites/forbestechcouncil/2021/11/18/how-real-world-evidence-is-shaping-the-future-of-healthcare/?sh=4519a7627fe3. Accessed June 6, 2022.
27. Tau N, Shepshelovich D. Assessment of data sources that support US Food and Drug Administration medical devices safety communications. JAMA Internal Medicine. 2020;180(11):1420-1426.
28. Maruszczyk K, Aiyegbusi OL, Torlinska B, Collis P, Keeley T, Calvert MJ. Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy. Journal of Patient-Reported Outcomes. 2022;6(1):1-11.
29. US Food and Drug Administration. Advancing real-world evidence program [Internet]. FDA; 2022 [cited 2023 Nov 3]. Available from:
https://www.fda.gov/drugs/developmentresources/advancing-real-world-evidence-program. Accessed October 28, 2022.
30. Dagenais S, Russo L, Madsen A, et al. Use of real-world evidence to drive drug development strategy and inform clinical trial design. Clin Pharmacol Ther. 2022;111(1):77–89.
31. Riskin D. How real-world evidence is shaping the future of healthcare. [Internet]. Forbes; 2021 [cited 2023 Nov 3]. Available from:
https://www.forbes.com/sites/forbestechcouncil/2021/11/18/how-real-world-evidence-is-shaping-the-future-of-healthcare/?sh=4519a7627fe3. Accessed June 6, 2022.
32. US Food & Drug Administration. FDA's Sentinel Initiative. 2019. [Internet]. FDA; 2022 May 20 [cited 2023 Nov 3]. Available from:
https://www.fda.gov/safety/fdas-sentinel-initiative
33. Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics—guidance for industry [Internet]. FDA; 2022 Jun 06 [cited 2023 Nov 3]. Available from:
https://www.fda.gov/media/124795/download
34. US Food and Drug Administration. Advancing real-world evidence program. [Internet]. FDA; 2022 Oct 28 [cited 2023 Nov 3]. Available from:
https://www.fda.gov/drugs/developmentresources/advancing-real-world-evidence-program
35. Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, Califf RM. Real-world evidence—what is it and what can it tell us. N Engl J Med. 2016;375(23):2293-2297.
36. Booth CM, Karim S, Mackillop WJ. Real-world data: towards achieving the achievable in cancer care. Nat Rev Clin Oncol. 2019;16(5):312-325.
37. Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol. 2005;58(4):323-337.
38. Hall K, Lazarus R, Platt R. Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care. 2010;S45-S51.
39. Balani P. Iqvia. [Internet]. informa; 2023 Nov 27 [cited 2023 Nov 3]. Available from:
https://turtlmedia.informa.com/story/future-global-pharmaceutical-regulatory-affairs-industry/page/4/1
40. Ribeiro L, Araújo M, Neves J. A review on the use of artificial intelligence in regulatory compliance. In Advances in Intelligent Systems and Computing. 2019; 952:489-498.
41. Wainberg M, et al. Deep learning in drug discovery. Mol Pharm. 2018;15(11):5346-5355.
42. Hazell A, et al. Use of natural language processing in drug development: A systematic review. J Biomed Inform. 2019;95:103208.
43. Jung K, et al. Quality control in pharmaceutical industry: A review. Pharmaceutics. 2021;13(1):16.
44. Li X, et al. Regulatory intelligence and application of natural language processing in drug safety. Drug Saf. 2019;42(2):159-169.
45. Food and Drug Administration (US). 2021. Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program [Internet]. FDA; 2023 May 15 Available from: https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program
46. Hosny A, Parmar C, Quackenbush J, Schwartz LH, Aerts HJ. Artificial intelligence in radiology. Nat Rev Cancer. 2018;18(8):500-510.
47. Thakkar S, Slikker Jr W, Yiannas F, Silva P, Blais B, Chng KR, Tong W. Artificial intelligence and real-world data for drug and food safety–A regulatory science perspective. Regul Toxicol Pharmacol. 2023;140:105388.
48. Cauchon NS, Oghamian S, Hassanpour S, Abernathy M. Innovation in chemistry, manufacturing, and controls-a regulatory perspective from industry. J Pharm Sci. 2019;108(7):2207-2237.
49. Gutierrez L, Cauchon N, Christian T, Giffin M, Abernathy M. The confluence of innovation in therapeutics and regulation: recent CMC considerations. J Pharm Sci. 2020;109:3524–34. doi: 10.1016/j.xphs.2020.09.025.
50. Boisseau P, Loubaton B. Nanomedicine, Nanotechnology in medicine. C R Hebd Seances Acad Sci. 2011;12(7):620-636.
51. Guidance D. Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; 2011.
52. Resnik DB, Tinkle SS. Ethical issues in clinical trials involving nanomedicine. Contemp Clin Trials. 2007; 28(4):433-441.
53. Guidance D. Considering whether an FDA-regulated product involves the application of nanotechnology. FDA; 2011.
54. Schneider CK, Kalinke U. Toward biosimilar monoclonal antibodies - regulatory and scientific considerations. N Engl J Med. 2017;376(11):1101–1103.
doi: 10.1056/NEJMp1700786.
55. US Food and Drug Administration (FDA). Personalized Medicine in Oncology: Companion Diagnostics. 2018. [Internet]. FDA [cited 2023 Nov 3]. Available from:
https://www.fda.gov/media/110246/download
56. Salmikangas P, Flory E, Reinhardt J. Regulatory challenges for advanced therapy medicinal products. Nat Rev Drug Discov. 2014;13(7):483–484. doi: 10.1038/nrd4344.
57. Woo JH, Kim EC, Kim SM. The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software. Expert Rev Med Devices. 2022;19(3):213-228.
58. Luxi N, Giovanazzi A, Arcolaci A, Bonadonna P, Crivellaro MA, Cutroneo PM, Trifirò G. Allergic reactions to COVID-19 vaccines: risk factors, frequency, mechanisms and management. BioDrugs. 2022;36(4):443-458.
59. European Medicines Agency (EMA). Questions and Answers on 3D Printing of Medicinal Products [Internet]. EMA; 2020 [cited 2023 Nov 3]. Available from:
https://www.ema.europa.eu/en/documents/other/questions-answers-3d-printing-medicinal-products_en.pdf.
60. Lam J, Kwee BJ, Ricles LM, Sung KE. Development of additive manufacturing-based medical products for clinical translation and marketing. In: Bone Tissue Engineering: Bench to Bedside Using 3D Printing. Cham: Springer International Publishing; 2022.p.267-292.
61. National Academies of Sciences, Engineering, and Medicine. Regulating medicines in a globalized world: the need for increased reliance among regulators; 2020.
62. Bolislis WR, De Lucia ML, Dolz F, Mo R, Nagaoka M, Rodriguez H, Kühler TC. Regulatory agilities in the time of covid-19: overview, trends, and opportunities. Clin Ther. 2021;43(1):124-139.
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Sharma, B., A. Gurung, P. Pradhan, D. Darjee, and N. K. Kotla. “Navigating the Regulatory Landscape: Key Trends Shaping Today’s Regulatory Affairs Environment”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 87-92, doi:10.22270/ijdra.v11i4.639.
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