China Food and Drug Administration (“CFDA”) issued a new circular on 27 May 2015 which is aimed to largely increase the registration fees to cover the relevant costs for the registration of drugs and medical devices. This new circular took effect as from the date of issue.
It has been more than 20 years that China has not increased its official drug registration fees1, and under the current regulations, the registration fees for an imported drug are RMB 45,300. As to medical devices, more than 6 years have passed since the last modification in 2009 which cancelled the collection of fees for registration of medical devices2.
This new circular is to implement the circular Cai Shui (2015) No.2 of National Development and Reform Commission (“NDRC”) and Ministry of Finance (dated 21 April 2015) which set for the general principles of collection of registration fees for drugs and medical devices as well as the circular of Fa Gai Jia Ge (2015) No. 1006 of the NDRC and Ministry of Finance (dated 12 May 2015) which details the definition of the scope of each registration fee.
“No losses and no gains” is defined as the new underlying principle when CFDA assesses and determines the costs for the registration of drugs and medical devices.
Based on the above new principle, the new standards for charging official fees for registration of drugs and medical devices are stipulated as follows, and according to the Circular of Fa Gai Jia Ge (2015) No. 1006, such new standards can be adjusted in general every five years based on the market.
1. Drugs registration fees
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2. Medical devices registration fees
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It should be noted that express services for registration of drugs and medical devices will be subject to a separate standard. Further, all travelling expenses for the examination in China or abroad for imported drugs and medical devices, such as transport, catering and accommodation, will be additionally charged.
Accompanied with the new standards, two implementing rules regarding the collection of registration fees for drugs and medical devices have also been promulgated at the same time to clarify the payment procedure.
The new circular also stipulates that the companies which are qualified as small enterprises according to the regulations of State Council may benefit from the exemption of part of the registration fees for innovative drugs or medical devices.