Last week, Remco Munnik, Asphalion´s Regulatory Information Director, attended the meeting at EMA for S&P subgroup and the Regulatory Optimization Group (ROG)
During the two day meeting, the partners presented and discussed vividly the work and progress within the work packages, laying a thorough basis for the second year of the project.
Igenomix receives EMA Orphan Drug Designation for its product indicated for Asherman’s Syndrome with Asphalion support
Igenomix, a company leader in reproductive genetics and experts in infertility problems announced that its product autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells (IGX1) was granted the Orphan Drug Designation (ODD) on March 15th 2017 by the European Medicines Agency (EMA). The product is aimed at the treatment of patients with the Asherman’s syndrome (AS), a rare disease defined by the presence of intrauterine adhesions.
Are you ready for implementing the changes? All devices in the market must be compliant with the new Regulations at the end of the transition period.
The Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety – Brussels, 5 April 2017