The State Council released a circular on Dec 29 and announced a change to drug import management in Boao Lecheng, an international medical tourism pilot zone in Hainan province.
According to the circular, the State Council made a temporary adjustment of the practice of the 36th article of China’s regulations for the implementation of the drug administration law, allowing Hainan provincial government to approve the import of a small amount of drugs (not including vaccines) that are badly needed for clinical use in the pilot zone.
According to the 36th article of the regulation, the application should be submitted to the drug regulatory department under the State Council.
Such imported drugs should be used in the designated medical institutions for a specified purpose, the circular stated.
Hainan government is required to strictly review the application submitted by medical institutions, track the imported drugs and ensure the safety of the importing channel.
Specific management methods will be made by Hainan government and approved by State Council departments on drug regulation and health.