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Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany: Are additional data requirements by the Fe...
Ruof, Jörg; Staab, Thomas; Dintsios, Charalabos-Markos; … - In: Health Economics Review 6 (2016) 46, pp. 1-11
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...
Persistent link: https://www.econbiz.de/10011803073
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Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany : are additional data requirements by the F...
Ruof, Jörg; Staab, Thomas; Dintsios, Charalabos-Markos; … - In: Health economics review 6 (2016) 46, pp. 1-11
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...
Persistent link: https://www.econbiz.de/10011586933