Rapid report
Concept for routine practice data collection for risdiplam acc. to the Law for More Safety in the Supply of Medicines (GSAV)
Report documents
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Extract of the rapid report
Concept for routine practice data collection for risdiplam acc. to the Law for More Safety in the Supply of Medicines (GSAV)
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Rapid Report
Concept for routine practice data collection for risdiplam acc. to the Law for More Safety in the Supply of Medicines (GSAV)
Additional information
Federal Joint Committee (GBA)
2026-09-18 A GBA decision was published.
Project details
- Project no.
- A21-131
- Commission
- Commission awarded on 07.10.2021 by the Federal Joint Committee (GBA).
- Report type
- Rapid report
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Muscles, bones and joints
- Note
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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 GBA 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 GBA.