[A21-142] Concept for routine practice data collection for fedratinib acc. to the Law for More Safety in the Supply of Medicines (GSAV)

Last updated 22.09.2022

Project no.:

Commission awarded on 21.10.2021 by the Federal Joint Committee (G-BA).

Report type:
Rapid report

Commission completed

Drug Assessment

Application field:


Routine practice data collection (RPDC concept):

In the case of new drugs that have entered the health care system via a special marketing authorization or as a drug for the treatment of a rare disease, the study data at the time of marketing authorization are usually not very informative for the early benefit assessment. In these cases, according to the Law for More Safety in the Supply of Medicines (GSAV), the G-BA can require the pharmaceutical company to collect routine practice data, including the associated analysis, for the benefit assessment. IQWiG prepares the concept for such a routine practice data collection on behalf of the G-BA.


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