The Drug Registration Management Measures were published on March 30, 2020. These measures are declared by Order No. 27 of the State Administration of Market Supervision and Administration approved on January 15, 2020. These drug registration measures will come into force on July 01, 2020.
According to article 33, “The sponsor should register the drug clinical trial plan and other information on the drug clinical trial registration and information disclosure platform before launching the drug clinical trial. During the clinical trials of drugs, the sponsor should continue to update the registration information and register the results of the clinical trials of the drugs after the completion of the clinical trials of the drugs. The registration information is publicized on the platform, and the sponsor is responsible for the authenticity of the registration information of drug clinical trials. The specific requirements for drug clinical trial registration and information disclosure shall be formulated and published by the Drug Evaluation Center.”
Also as per article 116, the sponsor shall be ordered to make corrections within a time limit if the sponsor has failed to register on the drug clinical trial registration and information disclosure platform as required before conducting the drug clinical trial and/or the clinical trial results and other information were not registered after the completion of the clinical trial of the drug.
The platform mentioned here is the disclosure platform launched by the Drug Evaluation Center of the State Drug Administration i.e. Chinadrugtrials.org.cn. The role of the primary registry i.e. Chinese Clinical Trial Registry is not yet clear, in relation to the regulation.