After a makeover and hiring spree, China's drug agency is romping and stomping on new reviews and approvals
When it comes to the reforms at China’s drug agency, now undergoing a name change, policy changes and even their outcomes are relatively easy to spot, but numbers are harder to come by. In a yearly report released last week, though, the agency offered some rare statistics to track its progress over the past few years and illuminate R&D priorities in the country.
The report highlights some big trends that have major implications for all companies looking to land a marketing OK and roll out new drugs in the booming Asian market. After beefing up the number of regulators on staff, China’s FDA slashed review times to a fraction of what they had been. There’s been a continued decline in the overall number of backlogged application, thanks to increased speed at the agency. In drug INDs alone, the Center for Drug Evaluation handled 542 applications and approved 481 of them — among those, 399 cases (shared by 170 drugs) were for novel drugs.
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