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 fee for registering a new locally-made drug will soar to 624,000 yuan ($100,637) compared with just 35,000 yuan in 2013, the China Food and Drug Administrator (CFDA) said in a statement late on Wednesday.
“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.
Despite the steep jump, drugmakers will welcome the move if it speeds up the process of getting drugs to one of the world’s fastest-growing markets. China’s fees were still lower than comparative levels in the United State 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 US$156,423, the regulator said. Generic drugs will cost US$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 US$185 billion by 2018, according to IMS Health. The country’s broader healthcare bill is estimated to reach US$1 trillion by 2020.
However, drug company executives say China has toughened the approval process, with companies forced to go through six to eight-year waiting periods to brings drugs to market.- Reuters