Russia tightens procedure for accelerated registration of drugs

Only the first three generics, along with generics intended for minors, as well as orphan drugs, will become subject of accelerated procedures for state registration in Russia, according to new amendments to the law "On the circulation of drugs," which were recently approved by the Russian State Duma (Parliament).

According to current Russian legislation, regular procedure of drugs’ examination at present takes about nine months, while the accelerated procedure should not exceed 80 days. So far, all generics could become subject of accelerated examination, however, according to the latest amendments, their number will be reduced by the first three items already started from the next year.

In the meantime, some Russian players in the field of pharmaceuticals have already welcomed the new amendments. According to Vasily Ignatiev, chief executive of R-Pharm, one of Russia’s largest pharmaceutical producers, one of the state goals is to provide priority to those companies that bring their generics to the market faster than their competitors.