After one year of testing the waters, China’s Drug Marketing Authorization Holder system is likely to have an earlier than expected start to the launch of final law amendment procedures, since the pilot scheme has significantly reduced investment duplication and encouraged pharma companies to file more innovative drug applications.
Since the Drug Marketing Authorization Holder (MAH) system was rolled out in 10 provinces in China under a trial program last year, coupled with support from local financial subsidies, China’s FDA had received 381 MAH applications by June this year, including some for global novel drugs.
Given the positive feedback, the new system is now expected to be promoted nationwide, and the details of implementation are...
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.
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.
Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.
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.
