Drug prices are top of policymakers’ minds in the US, where Senate Democrats have just passed legislation authorizing Medicare price negotiation, amid opposition from Republicans and the pharma industry. The bill is particularly significant given attempts by the previous and current administrations to reign in soaring drug prices, and a legal pathway is now finally in sight.
New Graft Probes Cast Shadow Over China's Drug Pricing, Reimbursement Systems
'Constant Improvement' Needed
While new legislation has pushed prescription drug pricing high up the political agenda for US lawmakers, the issue has also come into the spotlight again for Chinese regulators, which have just launched new investigations into two officials. While the two countries are taking drastically different routes to tackling pricing, the developments show compliance risks remain high in 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letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.