China, Regulatory

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.

Oncology and digestive drugs dominated the group of novel drug INDs approved last year. In biologics, oncology also takes up the biggest chunk of INDs, with hematology emerging as the runner-up.

Each IND took an average of 120 working days to evaluate, 1.09 times the period required by law — a drastic improvement from, say, 2012, when records show that almost half of the applications would take longer than 400 days to process.

Aggressive hiring of new staff was likely a key factor to speeding up the regulatory operation. With new units specializing in clinical testing and data management, the CFDA made 223 new hires, including two “chief scientists.”

The CDE also ramped up the priority review system, which was launched in 2016. By their count, first rounds for INDs, NDAs and ANDAs took an average of 39, 59 and 81 working days once they were accepted for priority review.

By the end of 2017, 423 applications of all sorts were included for priority review, with 45% of that being new drugs with clear clinical benefit (other common reasons included simultaneous application in the US/EU and first copycat). Rare disease drugs took up 5% of the cases.

The CDE’s 110 priority review approvals translated to 57 drugs, and 50 of those were approved in 2017. Overseas pharmas won big: Regeneron’s Eylea, AbbVie’ Humira, Incyte’s Jakafi and Celgene’s Vidaza (to be marketed by partner BeiGene) were among those approved through the priority review track.

Given the government revamp announced weeks ago, this would be the last report issued by a standalone CFDA. But changing its name to China Drug Administration and going under the purview of an umbrella market supervision agency likely won’t stop the regulators from building an even more aggressive system.


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