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The Russian Pharmacopeia: a reflection on the challenges to achieving greater alignment for biologics

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...

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

In this paper, a BioPhorum member team of experts in biologics and vaccines have summarized the current challenges linked to the registration of global products in Russian Federation. This paper describes some of the challenges faced by the industry in relation to current pharmacopoeial requirements for biologics and vaccines and presents a framework of options and activities that would lead to greater alignment with the ICH and the expectations of other regulatory agencies.

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Russia: In-country analytical testing of biopharmaceuticals, general recommendations

In 2020 the Russian agency adopted a new testing regimen for biological imports, that moves from testing all batches to testing the first imported batches and then potentially only annually. While the changes are intended to support industry and align with procedures in other regions there is concern that some parts of the approach and unintended consequences may worsen the supply of biological products to patients. This paper makes a series of proposals and recommendations to mitigate these concerns and help alignment between the Russian Federation requirements and those of other prominent agencies.

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