
The path of the drug to the market after its registration
Obtaining a registration certificate for a drug is by no means the last stage before entering the market, but rather one of the first. According to the Pharmvestnik portal, pharmaceutical companies are currently bringing drugs to market twice as long as, for example, 5 years ago.
As of the end of 2023, only half of the drugs registered in 2022 and a fifth of those approved in 2023 had entered the Russian market.
After registering a medicinal product, it is necessary to obtain permission for civil circulation from the manufacturing company. Medicines can also be imported with special permission from the Ministry of Health in case of shortage.
Moreover, in the first half of 2019, from the moment of registration to the receipt of the first permit for civil circulation, it took an average of four months.
It is interesting that over the past two years, none of the four registered foreign vaccines have entered the Russian market: two for the prevention of meningococcal infection from GlaxoSmithKline and Sanofi, one from GlaxoSmithKline against herpes zoster and one against hepatitis B from VBIV.
Experts attribute the difficulties of entering the Russian market also to the problematic inclusion of drugs in the list of vital and essential drugs (VED). Currently, getting on this list is not easy not only for foreign, but also for Russian drugs. And without inclusion in government guarantee programs, it often makes no sense to bring innovative foreign drugs to the market.
The List of Vital and Essential Drugs for 2023 includes only five new drugs, although at the end of 2021 and during 2022, the Ministry of Health commission for the formation of drug lists approved 19.
However, many pharmaceutical companies are optimistic and are ready to go through the necessary stages of bringing registered drugs to market.