Development and Registration of Drug Product across the various Regulatory Authorities (India, US, Europe, Australia, Japan)
Abstract
The process of obtaining regulatory approval for pharmaceuticals constitutes a critical and methodical framework aimed at validating the safety and effectiveness of innovative therapies. Although the essential stages of drug discovery, development, pre-clinical research, clinical trials, and approval remain consistent, regulatory bodies in various jurisdictions follow distinct criteria in their assessment and endorsement of pharmaceuticals. The evaluation of the safety and efficacy of chemical compounds identified during the drug discovery process is conducted through pre-clinical trials carried out in laboratory settings and utilizing animal models. Clinical research is conducted in three main phases to assess the drug's safety, effectiveness, and recommended dosage in humans. Drug clearance in India is managed by CDSCO, that closely complies to worldwide regulations while also taking into account extra factors particular for the Indian market, including affordability and availability. The FDA (Food and Drug Administration) is in the position of approving pharmaceuticals in the US including requires a New Drug Application (NDA) and extensive clinical trial data. In a similar spirit, the EMA in Europe emphasises safety for patients and scientific proof when examining applications. A comparable method is employed with Japan's PMDA, with careful assessment of the cultural and legal idiosyncrasies. Comparable information is additionally demanded by Australia's TGA, and these focusses on public safety and wellness findings.
Conclusion:
The regulatory approval process for pharmaceuticals is a rigorous global framework ensuring safety and efficacy. While the core stages-discovery, development, pre-clinical, and clinical trials are consistent, regional bodies such as India's CDSCO, the US FDA, Europe’s EMA, Japan's PMDA, and Australia’s TGA have unique criteria tailored to their local markets and priorities, such as affordability, cultural considerations, and public health focus.
Keywords:
Drug Discovery, Product development, pre-clinical study, clinical Trials, Drug approval procedure, ADME, CDSCO, FDA, EMA, PMDA, TGA
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References
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https://www.researchgate.net/publication/263657519_Comparison_of_Drug_Approval_Process_in_United_States_Europe
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https://academic.oup.com/jimb/article/36/6/775/5993612
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https://www.cabidigitallibrary.org/doi/full/10.5555/19762274218
9. Bland RD, Clarke TL, Harden LB. Rapid infusion of sodium bicarbonate and albumin into high-risk premature infants soon after birth: a controlled, prospective trial. Am J Obstet Gynecol [Internet]. 1976 Feb 1 [cited 2025 Jan 30];124(3):263–7. Available from:
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10. Freedman L, Gibson M. The Impact of Preclinical Irreproducibility on Drug Development. Clin Pharma and Therapeutics [Internet]. 2015 Jan [cited 2025 Jan29];97(1):16–8. Available from:
https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.9
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12. Xiong J, Liu J, Rayner S, Tian Z, Li Y, Chen S. Pre-Clinical Drug Prioritization via Prognosis-Guided Genetic Interaction Networks. Jönsson H, editor. PLoS ONE [Internet]. 2010 Nov 10 [cited 2025 Jan 29]; 5(11): e13937. Available from:
https://dx.plos.org/10.1371/journal.pone.0013937
13. Vermetten E, Bremner JD. Circuits and systems in stress. I. Preclinical studies. Depress Anxiety [Internet]. 2002 [cited 2025 Jan 29];15(3):126–47. Available from:
https://onlinelibrary.wiley.com/doi/10.1002/da.10016
14. Landis SC, Amara SG, Asadullah K, Austin CP, Blumenstein R, Bradley EW, et al. A call for transparent reporting to optimize the predictive value of preclinical research Nature [Internet]. 2012 Oct [cited 2025 Jan 29];490(7419):187–91. Available from:
https://www.nature.com/articles/nature11556
15. Andrade EL, Bento AF, Cavalli J, Oliveira SK, Schwanke RC, Siqueira JM, Freitas CS, Marcon R, Calixto JB. Non-clinical studies in the process of new drug development-Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Brazilian journal of medical and biological research [Internet]. 2016 [cited 2025 Jan 30];49(12): e5646. Available from:
https://doi.org/10.1590/1414-431X20165646
16. Curtis MJ, Hancox JC, Farkas A, Wainwright CL, Stables CL, Saint DA, et al. The Lambeth Conventions (II): Guidelines for the study of animal and human ventricular and supraventricular arrhythmias. Pharmacology & Therapeutics [Internet]. 2013 Aug [cited 2025 Jan 29];139(2):213–48. Available from:
https://linkinghub.elsevier.com/retrieve/pii/S0163725813000879
17. Andrews NA, Latrémolière A, Basbaum AI, Mogil JS, Porreca F, Rice ASC, et al. Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations Pain [Internet]. 2016 Apr [cited 2025 Jan 29];157(4):901–9. Available from:
https://journals.lww.com/00006396-201604000-00017
18. Baastrup C, Maersk-Moller CC, Nyengaard JR, Jensen TS, Finnerup NB. Spinal-, brainstem- and cerebrally mediated responses at- and below-level of a spinal cord contusion in rats: Evaluation of pain-like behavior Pain [Internet]. 2010 Dec [cited 2025 Jan 29];151(3):670–9. Available from:
https://journals.lww.com/00006396-201012000-00019
19. Smith AJ, Clutton RE, Lilley E, Hansen KEA, Brattelid T. PREPARE: guidelines for planning animal research and testing. Lab Anim [Internet]. 2018 Apr [cited 2025 Jan 29];52(2):135–41. Available from:
https://journals.sagepub.com/doi/10.1177/0023677217724823
20. EMA. Guideline on non-clinical local tolerance testing of medicinal products [Internet]. EMEA; 2015 [27/11/2015; cited 2025 Jan 30]. Available from:
https://www.ema.europa.eu/en/non-clinical-local tolerance-testing-medicinal-products-scientific-guideline.
21. Shaikh AI, Acharya CR, Shah AM, Moradiya MG, Patel JR, Patel AH, et al. An analysis of drug approvals in India over past 5 years. Int J Basic Clin Pharmacol [Internet]. 2024 Oct 23 [cited 2025 Feb 17];13(6):872–6. Available from:
https://www.ijbcp.com/index.php/ijbcp/article/view/5730
22. Jhuria A, Nagpal D, Verma R, Mittal V, Budhwar V, Kaushik D. Navigating the evolving landscape: A review of clinical trial regulations in India. Journal of Generic Medicines [Internet]. 2024 Aug 27 [cited 2025 Feb 17];17411343241277439. Available from:
https://journals.sagepub.com/doi/10.1177/17411343241277439
23. Henderson VC, Kimmelman J, Fergusson D, Grimshaw JM, Hackam DG. Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments. Ioannidis JPa, editor. PLoS Med [Internet]. 2013 Jul 23 [cited 2025 Jan 29];10(7): e1001489. Available from:
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Pal J, Manna A, Ahmed S, Chandra A, Ray J. Development and Registration of Drug Product across the various Regulatory Authorities (India, US, Europe, Australia, Japan). Int J Drug Reg Affairs [Internet]. 2025Jun.15 [cited 2026Jan.31];13(2):25-2. Available from: https://www.ijdra.com/index.php/journal/article/view/755
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