Over the course of August 2018, Biotherapy Services Ltd. (BTS) were awarded an MIA : IMP License. This was granted by the Medicines & Healthcare products Regulatory Agency (MHRA) as a recognition of the RAPID1-DFU Trial. Being the recipient of this prestigious license was a great motivator to pursue the work we are doing!
At the same time, the MHRA also awarded BTS with a Specials (MS) license, for the manufacture of Unlicensed Medicines. With RAPID Gel being an Investigational Medicinal Product in a Stage 2b development phase, its application is limited within the scope of the Clinical Trial. However, due to the high, unmet “special” clinical need surrounding Chronic Wounds, the MHRA recognised the potential of RAPID Gel and therefore approved its use As a response to an unsolicited order.