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 4 Non-RCT data required by the EMA as PAMs (N = 24)

Type of non-RCT PAM	n
Drug interaction and PK studies	7
Post-authorisation safety studies	5
Single-arm studies	4
Long-term observational or non-interventional studies	3
Registries	2
Cohort studies	2
Other	1

EMA European Medicines Agency, PAM post-authorisation measure, PK pharmacokinetics, RCT randomised controlled trial

ISSN: 2191-1991