[A21-130] Concept for routine practice data collection - autologous anti-CD19-transduced CD3+ cells

Last updated 17.11.2023

Project no.:

Commission awarded on 07.10.2021 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.

Federal Joint Committee (G-BA)

2023-11-16 A G-BA decision was published.
G-BA documents on this decision (German version)


Info Service (German)

Subscribe to daily updated information on projects, calls for tender, current vacancies and events as well as our press releases.


Contact form

Questions about commissions, publications and press releases can be sent to us via this form.

Contact form