State Food and Drug Administration: Announcement on matters related to the import of original reference drugs for clinical research of biological similar drugs

On November 30, 2018, the State Drug Administration issued the announcement on matters related to the one-time import of reference drugs for biological products for clinical trials (No 94, 2018), which made it clear that the applicant can apply for one-time import of reference drugs for clinical trials for the original research drugs that meet certain conditions In order to further implement the requirements of the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (Ting Zi [2017] No 42), and further promote the reform of "release and management service", according to the actual needs of domestic enterprises for the research and development of biological similar drugs, the original research drugs of the same enterprise that are not consistent with the origin of the original research drugs approved for import registration or clinical trials in China are decided The product is imported as a reference drug for clinical research of biological analogues The relevant matters are hereby announced as follows: 1 The applicant shall, as far as possible, select the original research drug approved for import registration or clinical trial in China as the reference drug for clinical trial of biological similar drugs 2、 In order to protect the safety of the subjects, if the applicant intends to choose the original research drug of the same enterprise which is not consistent with the approved import registration or the origin of the clinical trial in China as the reference drug, before the clinical trial starts, the comparative evidence between the original research drugs of different origins shall be provided or according to the requirements of the relevant technical guidelines for the research and evaluation of biological similar drugs of the drug regulatory authorities in China, After carrying out the comparative study of the original drugs from different places of origin and proving that they are comparable, they shall be submitted to the drug evaluation center of the State Food and Drug Administration in the form of supplementary application Only after the approval of the drug evaluation center of the State Food and drug administration, can the applicant use the original research drug from the unapproved origin for clinical trials 3、 The reference drug selected by the applicant for similarity comparative study at each stage of research and development shall be products from the same origin It is hereby announced State Food and Drug Administration May 27, 2019