China Drug Registration Regulation

Publication | March 2014

In February 2014, the China Food and Drug Administration (“CFDA”) invited second-round comments from the public regarding proposed amendments to the China Drug Registration Regulations (“DRR”). One of the proposed amendments touches upon patent protection for drugs in China.

The DRR came into effect in 2007. The original Article 19 provides that any party may submit an application for the registration of a patented drug up to two years prior to the expiry date of the patent, and market approval may only be given after the relevant patent expires.

In the first draft Amendment, the CFDA proposed to delete Article 19 altogether. The rationale was to bring the new DRR in line with the PRC Patent Law (as amended in 2008). The Patent Law provides that use of the patent solely for the purposes of scientific research and experimentation, or providing information for regulatory examination and approval shall not constitute infringement. The CFDA opined that the original Article 19 delayed the marketing of generic drugs which in turn informally extended the term of protection of the relevant patent. The implication of deleting Article 19 is that the time period for submission of the registration for a patented drug and grant of market approval is no longer restricted. In other words, third parties can then sell generic drugs, unless the patentee successfully enforces its patent rights. This would certainly impose a burden on patentees actively to take enforcement actions.

In the second draft Amendment, the CFDA now propose to retain Article 19 but with some amendments. In effect, any party may submit for the registration of a patented drug, anytime, and market approval may be given before the relevant patent expires. However, the market approval will only become effective after the expiry of the patent.

The new Amendment appears to strike a fairer balance between the interests of the patentee manufacturer and the public. It enables generic drugs to be marketed the moment the patent expires (as long as approval has been granted), and so it will not indirectly extend the term of protection of the relevant patents.The public consultation closed on 23 March 2014. We will be monitoring developments and will issue an update when the CFDA makes a further announcement.


Justin Davidson

Justin Davidson

Hong Kong