Reforming pharmaceutical regulation: a case study of generic drugs in Brazil
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منابع مشابه
Promoting and regulating generic medicines: Brazil in comparative perspective.
Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug ...
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Background: Supporting domestic production, by assuming its effect on the increase of accessibility, has been acknowledged as one of the main pharmaceutical policies from two dimensions of better provision of the drugs in the market and the increase of affordability by reducing prices. Therefore, it is expected from the domestic industries to produce pharmaceutical products that, in addition to...
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The analysis of the main characteristics of the pharmaceutical industry worldwide and market aspects of that industry in Brazil leads us to consider a high share of external dependency and oligopolization. This situation is not peculiar to our country, but is rather a global trend. Recent Government initiatives in Brazil, aiming at reducing that dependency, associated with the critical aspects ...
متن کاملMain Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)
Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants t...
متن کاملFactors influencing the preference for purchasing generic drugs in a Southern Brazilian city
OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory...
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