Enzymatic replacement therapy for lysosomal storage disorders: Drug evaluations review in Spain
In the European Union companies only need to demonstrate that the risk-benefit balance of the new drug is favourable to obtain the authorization to sell new drugs. Hence a comparison with available treatments, a cost-effectiveness analysis and the place in the therapy of the new drug are not require...
| Autores: | , |
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| Tipo de recurso: | artículo |
| Estado: | Versión aceptada para publicación |
| Fecha de publicación: | 2019 |
| País: | España |
| Institución: | Universidad de Barcelona |
| Repositorio: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/164980 |
| Acceso en línea: | https://hdl.handle.net/2445/164980 |
| Access Level: | acceso abierto |
| Palabra clave: | Terapèutica Anàlisi enzimàtica Lisosomes Farmacologia Therapeutics Enzymatic analysis Lysosomes Pharmacology |
| Sumario: | In the European Union companies only need to demonstrate that the risk-benefit balance of the new drug is favourable to obtain the authorization to sell new drugs. Hence a comparison with available treatments, a cost-effectiveness analysis and the place in the therapy of the new drug are not required. Therefore, it is necessary to carry out these analyses in an additional study. In Spain there is no national government agency, which conducts a centralized evaluation and makes decisions on funding and are the Pharmacy and Therapeutics committees that take mandatory decisions for the entire region. |
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