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2026-10-09 15:15:37 - Перевод -

ICH Q12 and Pharmaceutical Lifecycle Management: What Companies Need to Know About Post-Approval Changes

Nearly seven years after its finalization by the ICH Assembly in November 2019, ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) has officially moved from a forward-looking conceptual framework to an operational regulatory expectation. With the FDA advancing its implementation, the EU clearing legal pathways through Regulation (EU) 2024/1701, and...

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