2006
DOI: 10.1016/s1130-6343(06)74010-7
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Legislación sobre autorización de genéricos

Abstract: Although mechanisms of price regulation and financing policy are different throughout the member States, most countries have introduced measures to reduce the increase in expenditure on medicines, with generic products being an important aspect since they are less expensive than innovating medicines.

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Cited by 6 publications
(9 citation statements)
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“…And from the management point of view, these studies show whether it is worthwhile to have only one equivalent or to be able to define them as homologous medicines, which allows the inclusion of several drugs whose active principles are defined as therapeutic equivalents and which will be used interchangeably, depending on the costs or availability in the market ( through the studies of therapeutic equivalence in contrast to the original drug, in order to guarantee its interchangeability [11]. According to the results obtained in this study, carried out according to the current National and International regulations, both products showed a similar amount and rate of absorption, which guarantees their interchangeability.…”
Section: Discussionmentioning
confidence: 99%
“…And from the management point of view, these studies show whether it is worthwhile to have only one equivalent or to be able to define them as homologous medicines, which allows the inclusion of several drugs whose active principles are defined as therapeutic equivalents and which will be used interchangeably, depending on the costs or availability in the market ( through the studies of therapeutic equivalence in contrast to the original drug, in order to guarantee its interchangeability [11]. According to the results obtained in this study, carried out according to the current National and International regulations, both products showed a similar amount and rate of absorption, which guarantees their interchangeability.…”
Section: Discussionmentioning
confidence: 99%
“…2,3 In the European Union (EU), different forms of immediate-release products formulated for oral administration are considered as the same pharmaceutical form. 4 Similarly, the different esters, salts, ethers, isomers, isomer mixes, compounds or derivatives of an active ingredient are considered to be the same active ingredient, unless there are considerable safety and/or efficacy differences between them. Generic drugs are developed with the intention of substituting their branded equivalents and are manufactured without a licence from the manufacturers of the original branded drug.…”
Section: Definition and Use Of Generic Drugs Definitionmentioning
confidence: 99%
“…10 Over the past few years, the EU has been trying to reconcile the different sets of regulations on drug approval among all its member states. 4 The period of exclusive marketing rights for branded drugs in the EU is currently 10 years, although it can be extended to an additional year if any new indications of the drug bring about significant clinical benefits. 4,11 In order to market generic products more rapidly both in the USA and the EU, necessary studies for approval may begin before the period of exclusive marketing rights of branded drugs is over.…”
Section: Generic Drug Regulationsmentioning
confidence: 99%
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“…Los medicamentos genéricos (multifuentes) demuestran la seguridad y eficacia a través de los estudio de equivalencia terapéutica con el medicamento original con el fin de garantizar su intercambiabilidad (2).…”
Section: Introductionunclassified