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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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A new framework for greater alignment for the Russian Pharmacopeia

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...

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Russian release – how to manage the risks of new analytical testing in Russia

The Russian Federal Service for Surveillance in Healthcare currently mandates in-country testing for all batches of biologicals imported into its market. However, later this year, a new regulation will change the testing regimen. This will move from testing all batches (although only tests that are deemed ‘simple’) to testing the first batches of biological products that are imported and then on an annual basis – but performing all tests in the...

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