Comparative study (Europe versus United States) about the concept of generic drug
Keywords:
Drugs, Generics, Pharmaceutical legislation, Pharmaceutical Products.Abstract
Aim: The objective is to determine the similarities and differences between Europe and the United States on the scientific concept of generic medicine. The study is based on a comparative study of the current legislation in both regions.
Materials and Methods: Analysis of the current legislation in Europe and the United States in reference to the concept of generic medicine, analyzing each aspect of the definition in detail: composition (active substance and excipients), pharmaceutical form, quality characteristics, bioequivalence and the concept of reference medicinal product. Comparative study of the results obtained to conclude similarities and differences on the conceptual scope.
Results: Similarities and differences are observed on the scientific concept of generic medicine between Europe and the United States. In particular, differences on the concept “same active substance”and “same pharmaceutical form”, the use of excipients versus the reference medicinal product and the election of the reference medicinal product are observed. Moreover, differences on how to demonstrate bioequivalence with the reference medicinal product are also observed.Similarities on the concept of “same strength”, quality characteristics, labelling and indications versus the reference medicinal product are observed.
Conclusions: These differences will have an impact on the development, registration and marketing of a generic medicine by a company which decides to market a generic medicine globally in these regions.
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References
Directiva 2004/27/CE del Parlamento Europeo y del Consejo de 31 de marzo de 2004 que modifica la Directiva 2001/83/CE por la que se establece un código comunitario sobre medicamentos de uso humano (DO L 136, 30.4.2004)
Directiva 2001/83/CE del Parlamento Europeo y del Consejo, de 6 de noviembre, por la que se establece un código comunitario sobre medicamentos para uso humano (DO L 311, 28.11.2001)
Inactive Ingredient Search for Approved Drug Products page (Internet). Disponible en: http://www.accessdata.fda.gov/scripts/cder/IIG/
Orange Book page (Internet). Disponible en: http://www.accessdata.fda.gov/scripts/Cder/ob/default.cfm
Guidance on the investigation of bioequivalence (internet). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
Bioequivalence Recommendations for Specific Products page (Internet). Disponible en: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm
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