The Russian Pharmacopeia: a reflection on the challenges to achieving greater alignment for biologics
The Russian Pharmacopeia oversees the quality of pharmaceutical products for the Russian market, but Russian authorities often have a stricter application of requirements compared to other countries. Also, when moving from national to regional (Eurasian Economic Union) standards, some Russian requirements are likely to remain unchanged for local registrations.
These issues present regulatory challenges and may need new ways of working with regulators.
In 2020, BioPhorum members considered the standards applied to the manufacture of biologics for the Russian market and published An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics.
The original paper was published in January 2021 and, following member feedback, has now been updated. While the changes may seem subtle, the nuances are important to reflect the challenges around current Russian pharmacopeial requirements for biologics and vaccines.
However, the paper still presents a clear framework of options that would lead to greater alignment with ICH guidelines and the expectations of other regulatory agencies. It also includes the team’s thoughts on the changes required to align Russian standards and the benefits of closer collaboration between the Russian national regulator and other agencies.
The paper also summarizes the challenges around registering products in Russia, e.g. divergence of standards for testing compared to other prominent pharmacopeias, which are illustrated with real-life examples from BioPhorum members.
BioPhorum hopes its reflections can help Russian authorities to continue their progress towards greater harmonization and the delivery of medicines to patients.