With the Chinese government showing few signs of lifting stringent restrictions on international travel, the country’s drug makers are increasingly bearing the brunt of overseas approval delays due to the requirement to receive on-site facility inspections from foreign regulators including the US Food and Drug Administration.
Closed-Loop Inspections? Strict COVID Zero Policy Delays US FDA’s China Field Trips
Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a ‘quarantine bubble’ like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.
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A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
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The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.
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US pharma leadership is painting its mission, particularly its goal to end Medicare price controls, as patriotic and essential to America’s global dominance over China, a move that seems designed to align with President Trump’s priorities.
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A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.