China to Raise Registration Fees, Still Far Lower Than US, EU, Japan

Regulatory NewsRegulatory News | 29 May 2015 |  By 

The cost to register drugs and medical devices in China dramatically increased this week, and that could be a good thing for industry, Reuters reports.


While the market for healthcare products has expanded exponentially in China in recent decades, the China Food and Drug Administration (CFDA) has struggled to keep up with incoming applications.

In its 2014 Annual Report of Drug Evaluation, the Center for Drug Evaluation at CFDA said the number of backlogged applications rose from 14,235 in 2013 to 18,597 by the end of 2014. The report found the wait for drugs to be reviewed remained stable from previous years, at six to eight years.

According to Bioworld Today, CFDA has plans to chip away at that figure over the next three years, through increasing its staff, reducing redundancies and providing clearer guidance to companies.

For companies whose products are lost in the backlog, long delays can have considerable costs. On the other hand, patients also suffer by lacking access to new products, oftentimes for years after they are available elsewhere.

Raising Fees

In an announcement Wednesday, CFDA said the new registration fee for domestically manufactured products will be ¥624,000 CNY, roughly $100,000 USD, up from ¥35,000 CNY. The previous registration fees were devised in 1995, and had not kept up with inflation and other market forces, leaving the fees significantly lower than in other countries.

According to Reuters, the fee for registering imported drugs will be around $156,000 USD. Similar to other regulators, it will cost slightly less to register generic drugs, with domestic generics costing $81,000 and imported generics costing $140,000.

While the impact of the increased fees remains to be seen, increased revenue for CFDA could strengthen the agency as well as China's regional regulators, potentially decreasing review times in the process.


CFDA Press Release (Chinese), Reuters


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