On April 25 this year the China National Drug Administration (CNDA) published a proposed draft on Implementing Measures for Pharmaceutical Trial Data Protection.  The measures prevent other drug manufacturers from relying on earlier trial data to receive sales approval without permission from the owner of the earlier trial data.  The proposed draft extends the trial data protection term to up to 12 years compared with that of up to 6 years previously.  During the protection term, the CNDA will not approve marketing of the same drug[i] from a third party without permission of the owner whose drug gets a trial data exclusivity, except if the third party independently runs a trial and collects trial data.
Continue Reading

The State Council of China announced in April this year a plan to extend patent protection for up to five years for innovative drugs due to regulatory delay.  However, the State Council has not disclosed specific rules nor timetable for same.  Meanwhile, in May this year, China and the United States issued a joint statement