Market of registered pharmaceuticals for human use in Russia

When registering medicines in the territory of the Russian Federation, information about them is reflected in the state register of medicines. The GRLS contains basic information about the drug (registration certificate number, date of registration and re-registration, information about the holder of the RC and the form of release, etc.) Interestingly, GRLS can be opened not only online, but also imported in excel format, which allows analysis of available data.

So, as of 18.01.2020 60 821 medicinal products were registered in the Russian Federation (data on canceled RC was excluded from the analysis), with the majority of RU belonging to the Russian Federation holders (35,165), followed by Germany (3,714) and India (3,461). It is also interesting to trace the dynamics of the introduction of medicines in the period from 2000 to 2019 (see Figure 1).

According to GRLS data, 2008 can be called a year with the highest registering activity. During this period, more than 10 thousand medicines were recommended for registration. Since that time, the annual number of RC for pharmaceuticals has decreased by 10 times. For comparison: In 2019, 1,096 RC was received. Perhaps this registration “boom” of 2008-2011 was associated with a number of normative documents which were preparing for coming into force, for example, Federal Law No. 61 of 12.04.2010.

In 2020, there has been already registered 17 pharmaceuticals for human use, of which 3 belong to foreign manufacturers.

It should be noted that the data of GRLS cannot be called 100% accurate, because for some drugs (20) there is no information about the holder of the RC, for 87 there is no information about the country of the holder of the RC. In addition, information on the pharmacotherapeutic group is not standardized and not easy to analyze. Nevertheless, these materials allow to obtain an overall picture of regulatory activity in the territory of the Russian Federation.

However, despite the shortcomings of GRLS, other services operate on the basis of this resource. For example, the Ministry of Health of the Russian Federation has developed a single structured directory of medicines (ESKLP) . This resource is intended for use in the process of procurement of medicines for state and municipal needs using the EIS and also has the function of importing data from with a view to their subsequent analysis.