All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 28257/Florens is a carrier of the autosomal recessive disease spinal muscular atrophy (SMA). The donor/gametes were permanently blocked.

The pilot phase for the new medicines information system of the Federal Office for Safety in Health Care (BASG) begins on 21 January 2025.

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous cases of chikungunya have been recorded in the overseas department of La Réunion (Saint Pierre: Le Tampon).

Up-to-date information from the 09.12.-12.12.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

The opportunities of stem cell and other cell-based therapies raise great hopes in physicians as well as patients. Due to novel therapies, major progress is expected particularly in the areas of difficult-to-treat, chronic and incurable diseases. In order to prevent illegal profiteering, it is important for authorities to monitor this quickly evolving therapeutic area.