This, 25th year on the Russian market, PBN H+K Strategies places a particular focus on Policy Matters series of analytical briefing papers. In this issue we speak about the importance of systematic approach when localizing medicines manufacturing in Russia and when identifying benefits and upsides this process is supposed to bring international investors and local players.

Almost every year brings important changes to regulation of the Russian pharmaceutical industry. Occasionally Russian companies react positively, while their international counterparts almost never welcome the change. The list of measures speaks for itself: from the introduction of mandatory local clinical trials, price controls for vital medicines and obligatory compliance with GMP, through to the launch of processes to create a single regulatory regime for the pharmaceutical market in the Eurasian Economic Union, the “three’s a crowd” rule, yet another method for calculating prices for vital medicines and, soon, mandatory licensing. All of these measures have been introduced over the last few years. And all of these measures are related in one way or another to the notion of localization.

As always, we tried to be brief, clear and facts- and insights-based. PBN H+K Healthcare Practice team would appreciate any comments and queries you might have. Enjoy reading!

Read more (PDF)