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?

Table 5 Main topics of G-BA data requests beyond EMA data requirements^a

Efficacy	Safety	Effectiveness
Endpoint [8]	Comparator [5]	Incomplete population [3]
Comparator [4]	Endpoint [2]	Population not representative [2]
Long-term data [4]	Long-term data [2]
Patient number [1]	Post-marketing safety concerns [2]
Population [1]	Patient number [1]
	Population [1]

EMA European Medicines Agency, G-BA Federal Joint Committee
Numbers in brackets indicate the number of conditional appraisals concerned; more than one topic per category was possible for each appraisal
^aPer appraisal (N = 14)

ISSN: 2191-1991