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 Normative Document for the Russian market.
The biopharmaceutical industry is concerned because some of its methods are extremely complicated as its products are complex and often unique. How are the Russian official testing laboratories going to perform complicated tests that require specialized equipment and highly skilled scientists? And will they be able to perform these tests annually?
To address these challenges, BioPhorum has written a concept paper called General recommendations for in-country analytical testing of biopharmaceuticals in the Russian Federation.
“This paper helpfully describes the challenges currently faced by companies that market biopharmaceuticals in the Russian Federation,” said Ruth Schulz, Senior Director, Head of Biologics Global Regulatory Affairs, CMC at Takeda. “It clearly articulates potential unintended consequences of the reduced frequency and increased complexity of testing introduced by new regulations that seem, on their face, to be intended to support industry and align with procedures in other regions.”
The paper offers solutions to the Russian agency that will proactively mitigate the risks around medicine availability. It recommends how the agency could overcome these issues and ensure that Russian patients can access safe and efficacious high-quality products.
It suggests a more pragmatic approach to testing (e.g. if the technology is not in place, do not test the product) and reliance on:
- testing performed by the manufacturer (using the release results quoted on the certificate of analysis), or
- other testing laboratories that have the appropriate technology (i.e. other regulatory agencies or official testing laboratories certified by the World Health Agency).
However, this last option means that the Normative Document needs to reflect the same release specifications as those approved in other countries. If the tests are different, reliance on testing by a third party agency is not an option.
The paper compares Russian-specific verification requirements with those in other countries and, using a worked example on abnormal toxicity testing, details how some of the requirements of the Russian Pharmacopeia do not reflect modern approaches to product quality.
If a batch cannot be released by the official testing laboratory then there may be a perception that the manufacturer cannot supply the drug, rather than the agency is unable to test it. BioPhorum members are concerned that batches not being released will happen for multiple products and on repeated occasions.
In the past, the agency has managed this by recommending changes to a biomanufacturer’s analytical methods so that the agency could perform a test (which meant the biomanufacturer had to revalidate methods that it had used for years in other markets). Alternatively, it would use other methods that were often less robust or appropriate than the manufacturer’s.
BioPhorum commends the Russian agency for its changes to test a limited number of batches for biological products. Supported by BioPhorum’s proposed solutions, the changes will bring alignment between the Russian Federation requirements and those of other prominent agencies.
The BioPhorum team will continue the dialogue on this subject by sharing and promoting the paper with the main local industry group, the Association of International Pharmaceutical Manufacturers (AIPM). It also plans to identify a local, regional or European conference at which the paper could be presented and discussed.