The reform of imported drugs registration encourages the marketing of new drugs in China
On October 10 2017, the China Food and Drug Administration (“CFDA”) issued the Decisions Concerning the Adjustment of Imported Drug Registration (No. 35 Order by CFDA, “Decisions”). This implements the policy of encouraging new drug marketing following the earlier issuances of Opinions on Deepening the Reform of Evaluation and Approval System and Encouraging the Innovation of Drugs and Medical Devices by the General Office of the CPC Central Committee and the General Office of the State Council on October 8. This article will analyze the three major issues affected by the Decisions, including synchronized declarations of research & development for multi-regional clinical trials are permitted, the application for import marketing registration directly of drugs in MRCT and the removal of certain import drugs’ overseas marketing requirements.