The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
We at SCARLETRED are very proud to be the very first Austrian medtech company who got invited by EMA for obtaining a Qualification Opinion. Earlier today we travelled to the Netherlands (due to Brexit the EMA has recently moved its operation from London to Amsterdam) to discuss our new method and novel technology under the CHMP program (Committee for Medicinal Products for Human Use).
Today’s very fruitful and straight forward discussion was the result of our interaction with EMA which started about one year ago. During our visit we have started the Qualified Scientific Opinion process by the EMA which is a scientific opinion on the acceptability of a specific use of a method, such as the use of a novel methodology or an imaging method in the context of research and development. SCARLETRED aims to establish Scarletred®️Vision as the first objective digital skin imaging method and new Gold Standard for digital skin imaging and monitoring of drug safety/efficacy in preclinical and clinical trials. Stay tuned for more updates soon…