CREATIC has obtained the first hospital exemption for an advanced therapy medicinal product in the Czech Republic
This is an exceptional moment for advanced medicine in the Czech Republic and for patients whose standard treatment options are no longer sufficient.
A hospital exemption is a mechanism that makes an unauthorised advanced therapy medicinal product available, under strictly controlled conditions, to patients who have no other treatment options. In the Czech Republic, it is granted by the State Institute for Drug Control (SÚKL), which has now approved it for the very first time in the country, for a product of the CREATIC Centre of Excellence.
This step confirms that the Czech Republic, too, can build the professional, regulatory, and institutional environment needed to bring highly innovative therapies safely into clinical practice. It is a major achievement not only for CREATIC but for the wider system that allows advanced medicine to develop responsibly, with an emphasis on quality, safety, and genuine benefit to patients.
The hospital exemption was granted for an immunotherapy medicinal product based on autologous dendritic cells. It is intended for 24 paediatric and young adult patients with a specific type of high-risk solid tumour. Treatment will be administered at the Department of Paediatric Oncology of University Hospital Brno, and the authorisation covers these 24 patients over a period of two years.
This result rests on long and exceptionally demanding expert work. It brought together the development of the medicinal product, the setup of manufacturing and quality control, pharmacovigilance, regulatory expertise, and clinical readiness. It is also clear evidence that collaboration between leading expert teams, open dialogue with the regulator, and a responsible approach from public institutions can together open the way to treatment where the medical need is greatest.
Sincere thanks go to everyone who contributed to this breakthrough: the CREATIC and CREPROFA teams, specialists in regulatory processes and pharmacovigilance, partners from CZECRIN, and SÚKL for its expert assessment and for carrying out its role as the national regulator. The significance of this path is also underlined by broader support for the development of advanced medicine at the national level, including the role of the Ministry of Health of the Czech Republic.
This milestone offers hope that even patients with very serious illness can gain access to innovative therapies in the Czech Republic, provided there is a medical reason for their use and it is grounded in a rigorous professional and safety framework.
The first hospital exemption for an ATMP in the Czech Republic is a strong signal that Czech medicine can not only keep pace with Europe but also build its own path to patients who need help as soon as possible.
