On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments . Compared with the existing version effective since 2007 (“Existing Measures”), the Latest Revised Draft cancels certain time limitation rules dedicated to the protection of patent rights in the existing patent linkage mechanism and indicates that CFDA is minimizing its involvement in patent disputes related to the drug registration application. Specifically, with respect to those drug registration applications which are about drugs covered by existing patents, the Latest Revised Draft cancels the limitations about when certificates can be issued or effective, and keeps the previous revision of cancelling the limitations about when drug registration applications can be filed. In the meantime, according to previous explanation of CFDA as well as relevant content in the Latest Revised Draft, the dispute resolution mechanism newly introduced in the Latest Revised Draft is not likely to be available to patent disputes.
On July 25, 2016, CFDA published the latest "Measures for the Administration of Drug Registration (revised) for public comments on its official website. The public can send their comments on the Latest Revised Draft to the CFDA through emails before August 26, 2016.
