The Chinese drug regulator has increased the registration fees for medical devices and drugs quite sharply. China is the world’s 2nd biggest pharmaceutical market and a lack of resources and expertise suppresses the market’s ability to process a rising number of its applications.
The registration fee for a new regionally made drug is expected to rise by 624,000 Yuan which is round US$100,637 as compared to the fees of 35,000 Yuan recorded in 2013, according to statement released by the China Food and Drug Administration (CFDA). The regulator stated that handling of medical devices and drugs and going through the examination and approval process of these drugs and devices call for high costs in terms of labor and other physical resources. This cost needs to be borne by the applicants, mentioned the regulator.
In spite of the sharp rise, drugmakers in this industry will welcome the move if this allows in speeding up of the process of approval to launch drugs and devices in the world’s fastest growing pharmaceutical markets. On the other hand, the registration fees in China for new drugs and devices are still lower as compared to the levels present in Japan and United States, according to CFDA.
At present, China is battling with a growing backlog of devices and drugs that are awaiting approvals. Over 18,500 drugs were in line towards the end of 2014 which was up by a third from 2013 figures that reflected industry concern which is getting harder to get medical devices and drugs approved. CFDA stated that the previous fees that were set in 1995 have become highly inadequate compared to the accelerating incomes and product prices.