Global Perspectives on Drug Regulatory Bodies: Roles, Challenges, and Collaborative Frameworks
Authors
Rashed AhmedDOI:
10.56566/thrive.v2i2.322Published:
2025-09-30Issue:
Vol. 2 No. 2 (2025): SeptemberKeywords:
Drug Regulatory Bodies, Pharmaceutical Regulation, Pharmacovigilance, Quality Systems, Global Health CollaborationArticles
Downloads
How to Cite
Abstract
The article "Comparison of Drug Regulatory Bodies: EMA, DGDA, ISO, WHO, TGA, MHRA, and FDA" presents a comprehensive analysis of global drug regulatory organizations, focusing on their roles, responsibilities, and impact on public health. The research delves into the historical development, operational frameworks, and collaborative efforts of these agencies to ensure the safety, efficacy, and quality of pharmaceutical products and medical devices. By incorporating methodologies such as literature review, comparative analysis, critical evaluation, and historical contextualization, the study identifies key similarities and differences among these organizations. The article also examines the critical role of pharmacists in these regulatory bodies, emphasizing their involvement in drug evaluation, pharmacovigilance, and policy development. Furthermore, the study explores the concepts of In-Process Quality Assurance (IPQA) and In-Process Quality Control (IPQC), illustrating their necessity even in the presence of established Quality Control (QC) and Quality Assurance (QA) departments. By addressing challenges such as long approval times, high compliance costs, regulatory inconsistencies, and limited resources in developing countries, the research underscores the importance of global collaboration and regional adaptation in drug regulation. The article concludes by advocating for strengthened regulatory systems, enhanced international cooperation, and balanced approaches to ensure the rational use of drugs and equitable access to quality medicines worldwide.
References
Ahmad, Z., Rahim, S., Zubair, M., & Abdul-Ghafar, J. (2021). Artificial intelligence (AI) in medicine, current applications and future role with special emphasis on its potential and promise in pathology: present and future impact, obstacles including costs and acceptance among pathologists, practical and philosophical considerations. A comprehensive review. Diagnostic pathology, 16(1), 24. https://doi.org/10.1186/s13000-021-01085-4
Ahmed, R. (2024). Ensuring Quality Medicine is not a Single Event but Rather Combines Effects of a Pharmaceutical Company. Radinka Journal of Health Science, 2(2), 226-241. https://doi.org/10.56778/rjhs.v2i2.360
Al-Busafi, S. A., & Alwassief, A. (2024). Global perspectives on the hepatitis B vaccination: challenges, achievements, and the road to elimination by 2030. Vaccines, 12(3), 288. https://doi.org/10.3390/vaccines12030288
Ali, F., Neha, K., & Parveen, S. (2023). Current regulatory landscape of nanomaterials and nanomedicines: A global perspective. Journal of Drug Delivery Science and Technology, 80, 104118. https://doi.org/10.1016/j.jddst.2022.104118
Almeman, A. (2024). The digital transformation in pharmacy: embracing online platforms and the cosmeceutical paradigm shift. Journal of Health, Population and Nutrition, 43(1), 60. https://doi.org/10.1186/s41043-024-00550-2
Alowais, S. A., Alghamdi, S. S., Alsuhebany, N., Alqahtani, T., Alshaya, A. I., Almohareb, S. N., Aldairem, A., Alrashed, M., Bin Saleh, K., Badreldin, H. A., Al Yami, M. S., Al Harbi, S., & Albekairy, A. M. (2023). Revolutionizing healthcare: The role of artificial intelligence in clinical practice. BMC Medical Education, 23(1), 689. https://doi.org/10.1186/s12909-023-04698-z
Annaratone, L., De Palma, G., Bonizzi, G., Sapino, A., Botti, G., Berrino, E., ... & Alleanza Contro il Cancro (ACC) Pathology and Biobanking Working Group. (2021). Basic principles of biobanking: from biological samples to precision medicine for patients. Virchows Archiv, 479(2), 233-246. https://doi.org/10.1007/s00428-021-03151-0
Arnold, D. G., Amato, L. H., Troyer, J. L., & Stewart, O. J. (2022). Innovation and misconduct in the pharmaceutical industry. Journal of Business Research, 144, 1052–1063. https://doi.org/10.1016/j.jbusres.2022.02.026
Aslam, B., Khurshid, M., Arshad, M. I., Muzammil, S., Rasool, M., Yasmeen, N., ... & Baloch, Z. (2021). Antibiotic resistance: one health one world outlook. Frontiers in cellular and infection microbiology, 11, 771510. https://doi.org/10.3389/fcimb.2021.771510
Aziza, F. (2021). Comparison review of two regulatory agencies regulation: Therapeutic Goods Administration (TGA) and the European Medicine Agency (EMA) in relation to Good Manufacturing Practice (GMP) guideline. Majalah Farmaseutik, 17(2), 243-248. https://doi.org/10.22146/farmaseutik.v17i2.60237
Badnjević, A., Pokvić, L. G., Deumić, A., & Bećirović, L. S. (2022). Post-market surveillance of medical devices: A review. Technology and Health Care, 30(6), 1315-1329. https://doi.org/10.3233/THC-220284
Barker Scott, B. A., & Manning, M. R. (2024). Designing the Collaborative Organization: A Framework for how Collaborative Work, Relationships, and Behaviors Generate Collaborative Capacity. The Journal of Applied Behavioral Science, 60(1), 149–193. https://doi.org/10.1177/00218863221106245
Basu, A., Kuziemsky, C., de Araújo Novaes, M., Kleber, A., Sales, F., Al-Shorbaji, N., ... & Udayasankaran, J. G. (2021). Telehealth and the COVID-19 pandemic: international perspectives and a health systems framework for telehealth implementation to support critical response. Yearbook of medical informatics, 30(01), 126-133. DOI: 10.1055/s-0041-1726484
Burns, L., Le Roux, N., Kalesnik-Orszulak, R., Christian, J., Hukkelhoven, M., Rockhold, F., & O'Donnell, J. (2022). Real-world evidence for regulatory decision-making: guidance from around the world. Clinical Therapeutics, 44(3), 420-437. https://doi.org/10.1016/j.clinthera.2022.01.012
Chourasia, S., Pandey, S. M., Murtaza, Q., Agrawal, S., & Gupta, K. (2023). Redefining Industry 5.0 in ophthalmology and digital metrology: A global perspective. MAPAN, 38(2), 527. https://doi.org/10.1007/s12647-023-00633-1
Costanza-Chock, S., Raji, I. D., & Buolamwini, J. (2022, June). Who Audits the Auditors? Recommendations from a field scan of the algorithmic auditing ecosystem. In Proceedings of the 2022 ACM Conference on Fairness, Accountability, and Transparency (pp. 1571-1583). https://doi.org/10.1145/3531146.3533213
Eba, J., & Nakamura, K. (2022). Overview of the ethical guidelines for medical and biological research involving human subjects in Japan. Japanese Journal of Clinical Oncology, 52(6), 539-544. https://doi.org/10.1093/jjco/hyac034
Fourie Zirkelbach, J., Shah, M., Vallejo, J., Cheng, J., Ayyoub, A., Liu, J., ... & Theoret, M. R. (2022). Improving dose-optimization processes used in oncology drug development to minimize toxicity and maximize benefit to patients. Journal of Clinical Oncology, 40(30), 3489-3500. https://doi.org/10.1200/JCO.22.00371
Hayat, A. A., Keshavarzi, M. H., Zare, S., Bazrafcan, L., Rezaee, R., Faghihi, S. A., ... & Kojuri, J. (2021). Challenges and opportunities from the COVID-19 pandemic in medical education: a qualitative study. BMC Medical Education, 21(1), 247. https://doi.org/10.1186/s12909-021-02682-z
Heston, T. F., & Khun, C. (2023). Prompt engineering in medical education. International Medical Education, 2(3), 198-205. https://doi.org/10.3390/ime2030019
Khoo, Y. K., Lim, J. C., Tan-Koi, W. C., Kitikiti, N. S., & Sim-Devadas, A. L. (2024). Promoting collaboration of regulators and patients in improving drug safety and regulatory decision making. Drug Safety, 47(3), 217-225. https://doi.org/10.1007/s40264-023-01385-2
Lescrauwaet, L., Wagner, H., Yoon, C., & Shukla, S. (2022). Adaptive Legal Frameworks and Economic Dynamics in Emerging Tech-nologies: Navigating the Intersection for Responsible Innovation. Law and Economics, 16(3), 202–220. https://doi.org/10.35335/laweco.v16i3.61
Marshall, C. M., Federice, J. G., Bell, C. N., Cox, P. B., & Njardarson, J. T. (2024). An update on the nitrogen heterocycle compositions and properties of US FDA-approved pharmaceuticals (2013–2023). Journal of Medicinal Chemistry, 67(14), 11622-11655. https://doi.org/10.1021/acs.jmedchem.4c01122
Martins, A. C., Oshiro, M. Y., Albericio, F., & de la Torre, B. G. (2024). Food and Drug Administration (FDA) approvals of biological drugs in 2023. Biomedicines, 12(9), 1992. https://doi.org/10.3390/biomedicines12091992
Muteeb, G., Rehman, M. T., Shahwan, M., & Aatif, M. (2023). Origin of antibiotics and antibiotic resistance, and their impacts on drug development: A narrative review. Pharmaceuticals, 16(11), 1615. https://doi.org/10.3390/ph16111615
Ncube, B. M., Dube, A., & Ward, K. (2021). Establishment of the African Medicines Agency: progress, challenges and regulatory readiness. Journal of pharmaceutical policy and practice, 14(1), 29. https://doi.org/10.1186/s40545-020-00281-9
Niazi, S. K., & Mariam, Z. (2023). Computer-aided drug design and drug discovery: a prospective analysis. Pharmaceuticals, 17(1), 22. https://doi.org/10.3390/ph17010022
Ogbuagu, O. O., Mbata, A. O., Balogun, O. D., Oladapo, O., Ojo, O. O., & Muonde, M. (2023). Quality assurance in pharmaceutical manufacturing: Bridging the gap between regulations, supply chain, and innovations. International Journal of Multidisciplinary Research and Growth Evaluation, 4(1), 823-831. https://doi.org/10.54660/.IJMRGE.2023.4.1-823-831
Patil, R. S., Kulkarni, S. B., & Gaikwad, V. L. (2023). Artificial intelligence in pharmaceutical regulatory affairs. Drug Discovery Today, 28(9), 103700. https://doi.org/10.1016/j.drudis.2023.103700
Pramesh, C. S., Badwe, R. A., Bhoo-Pathy, N., Booth, C. M., Chinnaswamy, G., Dare, A. J., ... & Weiderpass, E. (2022). Priorities for cancer research in low-and middle-income countries: a global perspective. Nature medicine, 28(4), 649-657. https://doi.org/10.1038/s41591-022-01738-x
Rahman, M. A., Zamil, M. H., & Hoque, A. B. (2025). A meta-analysis of ERP and CRM integration tools in business process optimization. ASRC Procedia: Global Perspectives in Science and Scholarship, 1(01), 278-312. https://doi.org/10.63125/yah70173
Rani, J., Saha, S., Ferdous, F., & Rahman, M. A. (2024). Assessment of the Bangladeshi antibiotic market: implications of the WHO AWaRe classification and dosage form availability on antimicrobial resistance. Journal of Infection and Public Health, 17(12), 102587. https://doi.org/10.1016/j.jiph.2024.102587
Ransing, R., De la Rosa, P. A., Pereira-Sanchez, V., Handuleh, J. I., Jerotic, S., Gupta, A. K., ... & Jatchavala, C. (2022). Current state of cannabis use, policies, and research across sixteen countries: cross-country comparisons and international perspectives. Trends in psychiatry and psychotherapy, 44(suppl 1), e20210263. https://doi.org/10.47626/2237-6089-2021-0263
Rashid, H. (2023). Problem and Prospect of Pharmaceuticals Industry of Bangladesh amid LDC Graduation. Rashid, H.(2023). Problem and Prospect of Pharmaceuticals Industry of Bangladesh amid LDC Graduation. South Asian Journal of Social Studies and Economics, 20(4), 173-188. https://doi.org/10.9734/sajsse/2023/v20i4751
Stergiou, G. S., Menti, A., Asayama, K., De La Sierra, A., Wang, J., Kinoshita, H., ... & Alpert, B. (2023). Accuracy of automated cuff blood pressure monitors in special populations: International Organization for Standardization (ISO) Task Group report and call for research. Journal of hypertension, 41(5), 811-818. DOI: 10.1097/HJH.0000000000003403
Thapliyal, D., Karale, M., Diwan, V., Kumra, S., Arya, R. K., & Verros, G. D. (2024). Current status of sustainable food packaging regulations: global perspective. Sustainability, 16(13), 5554. https://doi.org/10.3390/su16135554
Udegbe, F. C., Ebulue, O. R., Ebulue, C. C., & Ekesiobi, C. S. (2024). Machine Learning in Drug Discovery: A critical review of applications and challenges. Computer Science & IT Research Journal, 5(4), 892-902. DOI: 10.51594/csitrj.v5i4.1048
Van der Schueren, B., Vrijlandt, P., Thomson, A., Janssen, H., & Dunder, K. (2024). New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus. Diabetologia, 67(7), 1159-1162. https://doi.org/10.1007/s00125-024-06162-z
Walker, H. L., Ghani, S., Kuemmerli, C., Nebiker, C. A., Müller, B. P., Raptis, D. A., & Staubli, S. M. (2023). Reliability of medical information provided by ChatGPT: assessment against clinical guidelines and patient information quality instrument. Journal of Medical Internet Research, 25, e47479. https://doi.org/10.2196/47479
Walter, Y. (2024). Managing the race to the moon: Global policy and governance in Artificial Intelligence regulation—A contemporary overview and an analysis of socioeconomic consequences. Discover Artificial Intelligence, 4(1), 14. https://doi.org/10.1007/s44163-024-00109-4
License
Copyright (c) 2025 Rashed Ahmed

This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with THRIVE Health Science Journal, agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution 4.0 International License (CC-BY License). This license allows authors to use all articles, data sets, graphics, and appendices in data mining applications, search engines, web sites, blogs, and other platforms by providing an appropriate reference. The journal allows the author(s) to hold the copyright without restrictions and will retain publishing rights without restrictions.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in THRIVE Health Science Journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).