Changes in china

In another encouraging step towards making China a leading destination for clinical drug trials, some critical developments were announced at The Executive Meeting of the State Council on the 12th April 2018.

  • From 1 May 2018, the import tariff of all common drugs including anticancer drugs, alkaloids with anticancer effects and the imported Chinese patent medicines will be reduced to zero. This will have a significant positive impact on your budgetary considerations.
  • To speed up the importation of innovative drugs, the clinical trial application has changed to the default approval, similar to that implemented through the FDA IND mechanism. This will speed up development timelines.
  • To strengthen your intellectual property rights, there will be a maximum of 6 years’ data protection/exclusivity period set for innovative chemical drugs, and the same varieties are not allowed to be listed during the protection period. The patent protection period for the maximum of 5 years will be compensated for drugs that are launched synchronously in China and globally.

This is an exciting time to investigate running a trial in China. George Clinical has a wealth of expertise in the country and the region. Contact me today to learn how we can help you make the most of these recent developments in China.