As China’s national anti-corruption campaign enters a new stage and goes deep into the local level, physicians in the country are becoming increasingly cautious about issuing prescriptions for high-value drugs, particularly in the oncology area.
Disappearing Prescriptions: China Corruption Campaign Prompts Physician Caution
Costly Cancer Drug Use Under Scrutiny
While there are already restrictions on the prescribing of cancer drugs in China, oncologists in the world’s second-largest pharma market are also now being expected to strictly avoid off-label use, especially of costly imported therapies from multinationals.
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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letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.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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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letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
• By
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.