Registration fees for drugs and medical devices in China set to soar

According to news agency Reuters, China’s drug regulator has steeply raised the fees required to register drugs and medical devices in the world’s second-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.

The China Food and Drug Administrator (CFDA) announced that, the fee for registering a new locally-made drug is set to soar to 624,000 yuan ($100,637) compared with just 35,000 yuan in 2013.

The regulator said: “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.”

As China’s fees are still lower than comparative levels in the United States and Japan, drugmakers will happily welcome the increase if it means that the process of getting drugs to one of the world’s fastest-growing market speeds up, despite the steep jump.

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

China is currently struggling with a growing backlog of drugs waiting to be approved as there were more than 18,500 drugs in line at the end of 2014, up by a third from a year before, which is reflective of the industry change that is getting harder to get medicines approved.

The Reuters article also suggested that the cost to register a new imported drug will be about $156,423, and generic drugs will cost $81,897 for domestic drugs to $140,247 for imported products.

According to IMS Health, 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, and the country’s broader bill is estimated to reach $1 trillion by 2020. 

However, drug company executives say China has made the approval process tougher, forcing companies to go through six to eight-year waiting periods to bring drugs to the market.