Drug registration of NanaBis in Europe is a key part of Medlab’s plans and the SME qualification allows it to start the process.
’s () European subsidiary has received formal SME (small or medium-sized enterprise) qualification from European Medicines Agency (EMA).
EMA is the European equivalent to the Australian TGA and the US FDA. As part of the registration, this allows MDC to apply for scientific advice, drug evaluation and registration of NanaBis.
It also provides MDC with the opportunity to obtain fee reductions up to 90% in the process.
NanaBi is a cannabis-based medicine which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).
Medlab chief executive officer Dr Sean Hall said: “This is a significant milestone for MDC. Drug registration of NanaBi 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.
“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.”
READ: Medlab Clinical proceeding to stage 2 for cannabis cancer trial
In late October 2018, Medlab successfully completed stage 1 of the NanaBis human trial on cancer patients at Royal North Shore Hospital.
The trial is progressing as planned and currently in stage II of the ethics approved trial.