Please use this identifier to cite or link to this item:
Title: [Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations].
Other Titles: Guía metodológica para la evaluación de la eficacia y la seguridad de nuevos fármacos: implementación de las recomendaciones de EUnetHTA.
Authors: Ubago Pérez, Ruth
Castillo Muñoz, María Auxiliadora
Banqueri, Mercedes Galván
García Estepa, Raúl
Alfaro Lara, Eva Rocío
Vega Coca, María Dolores
Beltrán Calvo, Carmen
Molina López, Teresa
Keywords: Comparative assessment;Efficacy and safety;Eficacia y seguridad;Evaluación comparada;Fármacos;Guideline;Guía;Methodology;Metodología;Pharmaceuticals
metadata.dc.subject.mesh: Drug Evaluation
European Union
Guideline Adherence
Technology Assessment, Biomedical
Issue Date: 3-Jan-2017
Abstract: The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model®, has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting "Evidence synthesis reports: pharmaceuticals" in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model®. In this paper, the methodology that AETSA has developed to create the guideline for "Evidence synthesis reports: pharmaceuticals" is described. The structure of the report itself is also presented.
metadata.dc.identifier.doi: 10.1016/j.gaceta.2016.10.005
Appears in Collections:Producción 2020

Files in This Item:
There are no files associated with this item.

This item is protected by original copyright

This item is licensed under a Creative Commons License Creative Commons