Regulatory System Changes in Russia: A Historical Review and Future Perspectives.

The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation make the process of marketing authorization in Russia much more challenging than in Europe. In the present review, an insight into the practical issues caused by the implementation of the new marketing authorization law from 2010 until now is provided. The outcome of the new law application is contrary to the old one from 1998, which was amended once in 2000. To date, it has already been revised 19 times. The reasons for the frequent amendments as well as future perspectives are provided.