China
Among products granted conditional approval in China over the 2020-22 period, the completion of confirmatory trials and conversion to traditional approval took up to a median of five years, according to a Pink Sheet analysis.
The message that the US may lose its lead in biotech to China appears to have bipartisan resonance on Capitol Hill. That sets a favorable context for the kickoff of the next user fee reauthorization process.
China’s NHSA expects to release the first list of innovative drugs to be covered by commercial health insurance in early December, but implementation, payment collection and data sharing are expected to be among the main hurdles ahead.
A new 10-year, government-supported R&D program in China will focus on new targets and emerging technologies which can be translated into first-in-class drugs and give birth to top players in the global pharma industry.
China's NMPA announces new measures designed to speed up access to imported medicines already launched abroad ahead of their final formal regulatory approval in China.
China’s new 30-day pathway for IND review and approval is designed to speed up the entry of qualified innovative medicines into clinical trials, but multiple eligibility criteria apply.
China’s NHSA in August released for the first time a preliminary list of innovative drugs under commercial insurance, along with a preliminary list of products under the National Reimbursement Drug List.
The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.
Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.
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.
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.
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.
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.
China’s State Council has released a wide-ranging set of policy incentives intended to eliminate regulatory barriers and improve market access for innovative drugs.