An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

BioPhorum members have come together to reflect on standards applied to the manufacture of biologics for the Russian Federation market. They have considered the current state described in the Russian Pharmacopoeia and regulations, as well as forthcoming changes in the region with a new set of standards and regulations defined through the Eurasian Economic Union (EAEU) banner.

A  team of experts in biologics and vaccines have summarized the current challenges, linked to the registration of global products in Russian Federation and illustrated them with examples and case studies. The challenges are articulated as:

  • Poor harmonization of standards for testing and specifications to other pharmacopoeias, in the region or in the world
  • The expectation that the same standards are applied to biologics and small molecules
  • The lack of flexibility of the implementation of the pharmacopoeia (even when it does not reflect progress of science)

The team shares approaches that have been successful with the agency, around the current situation, but with the proviso that these solutions may not be in the best interest of the patient. Additionally, the team sees ICH and WHO guidelines as widely accepted standards of proven applicability, such that conformance to them should not require justification even when they differ from Russian Federation market requirements. The team also reflect on the changes that are required to align Russian Federation standards and the associated benefits for all – industry, the national agency and Russian Federation patients.

In the transition from national to regional (EAEU) biopharmaceutical standards, some standards remained unchanged, and this undesirable ‘regional divergence’ continues to present regulatory challenges and may require new ways of working with regulators.  The urgency of the COVID-19 pandemic is expected to demonstrate further the power of harmonization and mutual recognition in enabling patient access to life-saving medicines and preventive therapies.


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Application of the Russian pharmacopeia to the registration of biologics September 2021.pdf
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