COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL
Abstract
This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA and
Brazil. Based on the information collected from various sources such as regulatory sites, Government websites,
discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, a
clear picture on the generic drug approval and registration process of each country was drawn. The different
authorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) of
USA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval and
registration process in the respective countries. After analysing the various requirements for the generic drug approval
in the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not well
defined. But FDA gives very much well defined requirements.
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References
States: Food and Drugs Administration; 2007
[updated 2015 July 01; cited 2007 Oct 04]. Available
from: http://www.fda.gov/generic drugs.
2. Food and Drugs Administration [Internet]. Thailand:
Food and Drugs Administration; 2004 [cited 2004
Oct 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 price
of innovation: New estimates of drug development
costs. Journal of Health Economics. 2003; 22:151-
85.
5. Patel N, Srivastava B, Songara R. Regulatory
consideration for generic drug registration in US,
Europe and Canada with special emphasis on filing
in European countries. Asian Journal of Pharmaceutical Sciences and Research. 2012; 2(7):9-
14.
6. Pugatch MP. Intellectual property and
pharmaceutical data exclusivity in the context of
innovation and market access. ICTSD-UNCTAD
dialogue on ensuring policy. Options for affordable
access to essential medicines.Belagio: 2004. p.12-16.
7. Chavan PN, Vijayan S, Joshi MM, Godse N,
Marialouis J, Kasibhatta R. Marketing authorisation
procedures in Europe: A Regulatory perspective.
International Journal of Pharmacy & Pharmaceutical
Science Research. 2011; 1(1):13-19.
8. Teresa M, Miguel S, Vagas E. Drug evaluation and
approval process in the European Union. 2006;
55(1):12-14.
9. Guttierrez E,de mesa Vazquez, lara PR. Strategic
issues in the development of a generic market:
Lession from Spain and Netherlands. Journal of
generic medicines. 2006; 3(2):121-30.
10. Nordfield K, Strasberger V. Creating eCTD
applications. Journal of generic Medicines. 2006;
3(2):140-6.
11. Hennings G. Market authorisation of medicinal
products in the European Union: Past, present and
future. Drug Information Journal. 2000; 34:793-800.
12. 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
interchangeable? A survey of Ontario patients and
physicians. Canadian Journal of Clinical
Pharmacology. 2005; 12:229-39.
13. European Union. Directive 2001/83/EC of the
European Parliament. Official Journal of the
European Communities. 2001; L311:67-100.
14. 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
interchangeable? Multiple N-of-1 randomized
crossover trials. Annals of Pharmacotherapy. 2005;
39:1188-93.
15. Ellender D, Marangoni E. EFPIA workshop: The
2001 review of European Union Pharmaceutical
Legislation. International Journal of Pharmaceutical
Medicines. 2001; 15(3):140-9.
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