To support and encourage the development ofbiosimilar drugs and meet the needs of the public use, it is now decided toimport the biological products that meet the following conditions for clinicaltrial reference drugs. The relevant matters are hereby announced as follows:

1. The range of biological products thatcan be applied for one-time import includes:

      (1) The original research biological products that have been approved forregistration in China, but are not available to the domestic market by drugresearch and development institutions or production enterprises;

      (2) Raw biological products that have been listed abroad and have not beenapproved for registration in China but have been approved for clinical trials.

2. The State Drug Administration shallentrust the Drug Evaluation Center to handle the acceptance, examination andapproval of the one-time import of biological products for clinical trials.