With a press release on 24 July 2015 the European Medicines Agency (EMA) announced that they had started a review of InductOs, an implant kit for bone development. The kit, containing Dibotermin as active ingredient and the absorbable collagen sponge ACS as excipient, is used for patients with tibia fractures or spinal disc issues.
The EMA's activity follows the inspections of Dutch and Spanish GMP inspectors. During their inspection at the manufacturer of the ACS component, Integra Life Sciences Corporation (ILS), located in US, they identified several major deficiencies in 2014. The following re-inspection in April 2015 showed that the plan for corrective actions were not fulfilled and the contamination of ACS with particulate matter was not under control. Because of this fact, the inspectors called for ceasing the importation of the products into the European Union (EU).
The EMA stated in their press release:
"There is at present no indication of risk to patients linked to the inspection findings. Healthcare professionals using InductOs should follow the instructions in the product information as usual. As with any medicinal product, patients who have received InductOs implants should speak to their healthcare professional if they have any questions."
It will now be EMA’s Committee for Medicinal Products for Human Use (CHMP) assignment to review the influence of the deficiencies on the products overall benefits and risks and to make a recommendation as to whether any changes are needed to its marketing authorisation. This will then be sent to the European Commission for a final and legally binding decision. In the meantime, the CHMP sent a catalogue of questions to be addressed by the marketing authorisation holder for InductOs to asses the benefit - risk relations, product supply and manufacturer.
Read more in EMAs press release about the review of InductOs and about the questions to the marketing authorisation holder Medtronic BioPharma B.V., Netherlands.