Healthcare around the world is at a turning point – we have entered a new era of high patient expectations, aging populations and socioeconomic constraints. Using real-world evidence (RWE) and Big Data analysis from real-world data (RWD) not only makes it possible to apply knowledge gained from huge volumes of medical information, but also creates serious methodological, legal and ethical problems. Currently, there is an urgent need to conduct research on real clinical practice, to eliminate the existing uncertainty in the data on the efficacy and safety of drugs in routine medical practice, therefore, in 2021, it was decided to create the journal “Real-world data & evidence” (MyRWD) dedicated to publication the RWE/RWD results.