Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?

OBJECTIVES: The aim of this study was to compare post-authorisation measures (PAMs) from the European Medicines Agency (EMA) with data requests in fixed-termed conditional appraisals of early benefit assessments from the German Federal Joint Committee (G-BA). METHODS: Medicinal products with complet...

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Detalles Bibliográficos
Autores principales: Ruof, Jörg, Staab, Thomas, Dintsios, Charalabos-Markos, Schröter, Jakob, Schwartz, Friedrich Wilhelm
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2016
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5042914/
https://www.ncbi.nlm.nih.gov/pubmed/27687714
http://dx.doi.org/10.1186/s13561-016-0124-4

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