Russian authorities are making progress in aligning with international pharmaceutical guidelines but, like many other countries, are on a journey towards using these to improve the manufacture of biologics for their home market. Yet, some challenges remain.
The Russian Pharmacopeia is a comprehensive reference document that oversees the quality of its pharmaceutical products. However, compared to other countries’ publications, Russian authorities sometimes tend toward the stricter application of requirements, e.g. applying the same standards and expectations for small and large-molecule products.
Also, in the transition from national to regional (Eurasian Economic Union, EAEU) biopharmaceutical standards, some Russian standards are predicted to remain unchanged for local registrations. These issues continue to present regulatory challenges and may require new ways of working with regulators.
This is why BioPhorum members have reflected on the standards applied to the manufacture of biologics for the Russian market and published An industry view on the application of the Russian Pharmacopeia: proposal for a different approach for biopharmaceuticals .
A new framework
The paper describes some of industry’s challenges about current Russian pharmacopeial requirements for biologics and vaccines. It also presents a framework of options and activities that would lead to greater alignment with ICH guidelines and, therefore, with the expectations of other regulatory agencies.
The paper includes the team’s reflections on the suggested changes required to align Russian standards and the associated benefits of closer collaboration between the Russian national regulatory agency and other agencies.
For example, ensuring that testing recommendations for biologics are at the helm of science, new developments and technologies will allow the current high standards of the official testing laboratories to be maintained and even improved. Also, harmonizing requirements would enable simultaneous submissions to Russian and other regulatory agencies and so life-saving medicinal products would reach Russian patients much quicker.
The paper summarizes the challenges linked to registering products in Russia. These include poor harmonization of standards for testing and specifications to other pharmacopeias, expectations that the same standards are applied to biologics and small molecules, and the lack of flexibility when implementing the pharmacopeia. All of these are illustrated with real-life examples from the day-to-day work of BioPhorum members and their knowledge and expertise in regulatory science.
The soon-to-be-implemented regional EAEU Pharmacopeia is seen as a great asset by the BioPhorum team and, together with the urgency of the Covid-19 pandemic, will demonstrate the power of harmonization and mutual recognition for patient access to life-saving medicines and preventive therapies.
BioPhorum hopes to further a dialogue with Russian authorities so that its suggestions can help them continue their progress towards greater harmonization and the delivery of medicines to patients.