China’s State Council updated the Drug Administration Law to enforce lifecycle accountability across drug development and commercialization, signaling stricter oversight and longer regulatory reach. The amendments aim to speed approvals while holding sponsors accountable for post‑market quality, pharmacovigilance, and manufacturing continuity. Regulatory observers said the changes could reshape sponsor strategies in China—encouraging stronger local regulatory operations, tighter supply‑chain controls, and earlier engagement on long‑term safety commitments. International biopharma companies with China programs will need to reassess compliance playbooks and product‑lifecycle investments to align with the revised framework. Clarification: lifecycle accountability extends regulatory responsibilities from initial approval through long‑term manufacturing, safety monitoring, and product changes that occur after market entry.
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