China jacks up registration fees for medical devices, drugs

May 28, 2015 By MassDevice Leave a Comment

(Reuters) — The China Food & Drug Administration steeply raised the fees required to register medical devices and drugs in the world’s 2nd-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.

The fee for registering an imported Class III medical device will be ¥308,800 ($49,802), the CFDA said in a statement late yesterday. The fee for locally made Class III devices will be ¥153,600 ($24,772).

Provincial-level officials will decide the fees for registering new, locally made devices; new imports will be charged ¥210,99 ($YY), according to Osmunda Group.

The fee for registering a new locally-made drug will soar nearly 188% to ¥624,000 ($100,637) compared with just ¥35,000 ($5,645) in 2013, the CFDA said in a statement late yesterday.

“Handling drug and medical device applications and going through the process of examination and approval requires high costs in terms of man power and physical resources. This cost should be borne by the applicants,” the regulator said.

According to Drug Test Ninja, despite the steep jump, drugmakers will welcome the move if it speeds up the process of getting drugs to 1 of the world’s fastest-growing markets. China’s fees were still lower than comparative levels in the U.S. and Japan, the CFDA said.

China is struggling with a growing backlog of drugs waiting for approval. There were more than 18,500 drugs in line at end of 2014, up by a third from a year before, reflecting industry concern that it is getting harder to get medicines approved.

The fees vary for imported products, generic drugs and medical devices. The cost to register a new imported drug will be about $156,423, the regulator said. Generic drugs will cost $81,897 for domestic drugs to $140,247 for imported products.

The CFDA said the previous fees, which were set in 1995, had become “severely inadequate” compared to fast-rising incomes and product prices.

China’s healthcare market is a magnet for drugmakers, medical device firms and hospital operators, with spending on medicines alone set to hit as much as $185 billion by 2018, according to IMS Health. The country’s broader healthcare bill is estimated to reach $1 trillion by 2020.

However, drug company executives say China has toughened the approval process, with companies forced to go through 6- to 8-year waiting periods to brings drugs to market.

($1 = ¥6.2005)

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