After a busy year filled with regulatory reforms to erase a lengthy drug approval lag, and speed up new drug approvals, China FDA officials finally have a moment to reflect on what's good, what's bad and what's ugly.
Stay Calm And Quickly Carry On: Five Takeaways As China FDA Builds Capabilities
Growing its reviewers from 120 to 800 in a short time, the China FDA is now struggling with its very existence. After a productive year filled with over 30 new drug approvals, China's top drug regulatory agency, in its first annual report since massive regulatory reforms were announced, highlights five major trends to watch in 2018.
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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letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.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.