Volume : 11, Issue : 11, November – 2024

Title:

REULATORY STRATEGIES FOR EXPEDITED DRUG APPROVAL PROCESS IN USA, EU & JAPAN

Authors :

SYED ARSHIYA*, M. V. NAGABHUSHANAM, ADILAKSHMI CH,G RAMAKRISHNA, M BEENA DEVI

Abstract :

This study provides a comprehensive and comparative analysis of the regulatory approval processes for generic drug products across Latin American countries. With the rising need for affordable medications, generic drugs play a critical role in expanding healthcare access. However, significant differences exist in the regulatory frameworks and approval timelines in Latin America, impacting the availability and affordability of generics. This research examines the requirements, documentation, bioequivalence studies, and timelines mandated by key regulatory bodies, including ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), and others. Key findings reveal a substantial variance in approval times and procedural complexity, with some countries implementing stringent regulatory processes, while others face challenges such as limited resources, capacity constraints, and bureaucratic delays. The study also explores efforts toward regional harmonization led by organizations like PAHO and PANDRH, which aim to standardize regulations across Latin America to streamline approval processes. Through comparative analysis, this research identifies best practices and recommends improvements, such as greater regional collaboration, capacity building for regulatory agencies, and simplified approval pathways. These recommendations aim to facilitate faster, safer, and more cost-effective access to generic drugs in Latin America, ultimately supporting public health goals by making essential medications more accessible to diverse populations across the region.
Keywords: Latin American countries, Regulatory frameworks, Approval Process, Generic Drugs

Cite This Article:

Please cite this article in press Syed Arshiya et al Regulatory Strategies For Expedited Drug Approval Process In USA, EU & Japan.,Indo Am. J. P. Sci, 2024; 11 (11).

Number of Downloads : 10

References:

1. US Food and Drugs Administration [Internet].UnitedStates: Food and Drugs Administration; 2007[updated 2015 July 01; cited 2007 Oct 04]. Availablefrom: http://www.fda.gov/generic drugs.
2. Food and Drugs Administration [Internet]. Thailand:Food and Drugs Administration; 2004 [cited 2004Oct 21]. Available from:http://www.fda.org/Thailand.
3. Ministry of Public Health [Internet]. Thailand:Ministry of Public Health [cited 2012 Nov 26].Available from:http:://www.eng.moph.go.th.
4. Dimasi JA, Hansen RW, Grabowski HG. The priceof innovation: New estimates of drug developmentcosts. Journal of Health Economics. 2003; 22:151-85.5. Patel N, Srivastava B, Songara R. Regulatoryconsideration for generic drug registration in US,Europe and Canada with special emphasis on filingin European countries. Asian Journal of
5. Knezevic I, Griffiths E, (2011) Biosimilars — Global issues, nationalsolutions, Biologicals 39(5): 252-255.
6. Gravel P, Naik A, Le Cotonnec J.Y (2012) BiosimilarrhG-CSFs: Howsimilar are they? Target Oncol, 7 pp 3-16
7. Prashant Pandya (2017) “Managing Complex R&D Projects- Strate-gies from Project Management Perspectives”. Chronicles of Pharma-ceutical Science 1(3): 113-117.
8. Pombo ML, Di Fabio JL, Cortés Mde L (2009) Cortes Review ofregulation of biological and biotechnological products in LatinAmerican and Caribbean countries, Biologicals, 37 (5): 271-276 .
9. Minghetti P, Rocco P, Cilurzo F, Vecchio LD, Locatelli F,et al (2012) Theregulatory framework of biosimilars in theEuropean Union. DrugDiscovery Today 17(1-2): 63–70.
10. Kay J (2011) Biosimilars: a regulatory perspective from America.Arthritis Research & Therapy 13(3): 112
11. Rotenstein, LS, Ran N, Shivers JP, Yarchoan M, Close KL, et al (2012)Opportunities and Challenges for Biosimilars.
12. Brahmaiah Bonthagarala, Regulatory Requirements for Registration of Generic Drugs in “BRICS” Countries, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 (November-December 2016), 20-39.
13. Brahmaiah Bonthagarala,Current Regulatory Requirements for Registration of Medicines, Compilation and Submission of Dossier in Australian Therapeutic Goods Administration, International Journal of Advanced Scientific and Technical Research, ISSN 2249-9954, Issue 6 volume 6, November-December 2016, 144-157.
14. Brahmaiah Bonthagarala,Comparison of Regulatory Requirements for Generic Drugs Dossier Submission in United States and Canada, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 (November-December 2016), 1-19.
15. Brahmaiah Bonthagarala, Regulatory Requirements for Marketing of Generic Drugs in USA,International Journal of Pharmaceutical Research and Bio-Science, ISSN: 2277-8713, IJPRBS, 2017; Volume 6(2): 178-195.
16. 16.Brahmaiah Bonthagarala,Guidelines for bioavailability and bioequivalence studies: A Review, The Pharma Innovation Journal 2018; 7(7): 661-666, ISSN (E): 2277- 7695.
17. Brahmaiah Bonthagarala et al, Generic Drug Registration and Regulatory Requirements in European Countries,World Journal of Pharmaceutical Research, 2018, Volume 7, Issue 16, 800-815.
18. Pereira J A, Holbrook A M, Dolovich Goldsmith C,Thabane L, Douketus J D, Crowther M, Bates SM,Ginsberg J S. Are brand name and generic warfarin in terchangeable Multiple N-of-1 randomized crossover trials. Annals of Pharmacotherapy. 2005;39:1188-93.
19. Ellender D, Marangoni E. EFPIA workshop: The2001 review of European Union PharmaceuticalLegislation. International Journal of PharmaceuticalMedicines. 2001; 15(3):140.