Australian medical life sciences company, Medlab Clinical (ASX:MDC), has received formal SME qualification from the European Medicines Agency through its recently incorporated wholly-owned subsidiary MDC Europe.
The European Medicines Agency (EMA) is the European regulator and equivalent to the Australian TGA and US FDA.
The registration allows Medlab to apply for scientific advice, drug evaluation and registration of its patented cannabis-based medicine, NanaBis. It also provides the company with the opportunity to obtain fee reductions up to 90 per cent in the process.
According to CEO Dr Sean Hall, “This is a significant milestone for MDC. Drug registration of NanaBis is key part of the Company’s plans and this qualification allows us to start the process into Europe.
"Drug evaluation and registration fees with the various agencies are expensive, but at the same time, a much needed and real cost in bringing a drug to market and we welcome the opportunity obtain fee reductions and as a result significant savings.”
Dr Hall added, “Personally I would like to thank EMA for their collaborative approach in this regard, and very much look forward to escalating the NanaBis evaluation with EMA as we move closer to an approved drug in the EU.”