Regulatory Governance

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The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

Driving the harmonization of regulatory requirements – one country at a time  Regulations play a significant role in assessing marketing authorizations for drug products that are submitted for approval. Yet, regulatory agencies often differ in their degrees of harmonization. This has created an environment of divergence, in which countries each have unique standards, requirements, submissions and review processes.  The potential...

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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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