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China reorganises administrative authorities – new regulatory authorities for Life Sciences and Healthcare sector

China
20/03/2018
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Recently, the 13th National People’s Congress (“NPC”) of the People’s Republic of China passed the Programme of Reforming the Institutions of the State Council (“Programme”) on the 17 March 2018. According to the Programme, some of the institutions under the State Council will be reorganised. This includes the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”), which are key regulatory authorities for the life sciences and healthcare industries. Both authorities will be combined with other authorities to create giant, new regulatory authorities.

We have summarised the key reorganisation plans in the life sciences and healthcare areas below.

  • The National Health Commission (“NHC”) will be established
  • The State Administration for Market Supervision (“SAMS”) will be established
  • The State Medical Insurance Bureau (“SMIB”) will be established

The detailed measures of such reorganisation are expected to be issued soon. Currently, it is difficult to predict what influence such reorganisation will have on the current regulatory regime of the life sciences and healthcare sectors. It is expected that the new authorities may restructure the regulatory regime in a more organised and efficient way.

During the reorganisation process, it may be a difficult for business entities to identify the competent regulatory authority. This will continue until the functions of every department in each authority are clarified. CMS will keep a close eye on the process and provide timely updates.

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