2018 marked several historic regulatory milestones for the biopharma sector in China, among them the approval of the first domestically developed novel cancer drug, a simmering trade war with the US, and more controversially the birth of the world's first gene-edited babies. This was aside from the leaps and bounds of the country's regulatory agencies to speed up innovative new therapies' market entry.
Eight For 8: Things You Need To Know About China Biopharma Regulation In 2018
The Pink Sheet's pick of eight major events that captured major regulatory developments in China’s dynamic, highly fluid biopharma scene in 2018.
More from China
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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letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.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.
More from Asia
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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.