Bone marrow donation and transplantation - Inspection

The Agence de la biomédecine has been in charge of biovigilance since the publication of Decree no. 2016-1622 of November 29, 2016 on biovigilance and vigilance systems in medically assisted procreation.

As part of the monitoring of hematopoietic stem cell (HSC) transplantation activity, a national inspection-control guideline (ONIC) covering the organization and activity of biovigilance, as well as the methods for collecting and analyzing the data required to monitor HSC transplants, has been included in the ARS inspection program for the 2025 financial year.

The ten missions planned for 2025 throughout France will be carried out jointly by the Agence de la Biomédecine and the ARSs, within a framework defined by a national cooperation agreement drawn up by the General Secretariat of the Ministries in charge of Social Affairs.

An inspection grid is proposed as part of this ONIC.