NMPA Issued the Announcement on Issues Concerning the Import of Reference Drugs for Clinical Research of Biosimilar Drugs

On November 30, 2018, NMPA issued the Announcement on Issues Pertaining to the One-off Import of Reference Drugs for Biologicals in Clinical Trials (Announcement No. 94 of 2018), clarifying that the applicant can apply for one-off import of brand-name drugs that meet certain conditions as reference drugs for clinical trials. To further implement the relevant policies set forth in the Opinions on Deepening the Reform of the Review& Approval System to Encourage the Innovation of  Drugs and  Medical Devices (General Office [ 2017 ] No. 42), and further promote the reform of Streamlining Administration, Delegating More Powers to Lower-level Governments and Society, Improving Regulation and Optimizing Services, in light of the domestic enterprises' actual demand of biosimilar R&D, NMPA decided to grant the one-off import of brand- name drugs as reference drugs for biosimilar clinical research that are produced by the same manufacturer in different places of origin, and have been approved for import registration or clinical trial in China. The Announcement was issued on May 28, 2019. The relevant issues are hereby announced as follows:

I. Applicants should select, as far as practicable, the brand-name drug that has been approved for import registration or clinical trial in China as reference drugs for biosimilar clinical trials.

II. Where the applicant intends to select brand-name drugs as reference drugs for biosimilar clinical research that are produced by the same manufacturer in different places of origin, and have been approved for import registration or clinical trial in China, in order to protect the safety of the subjects, prior to the clinical trials, comparable evidence of the brand-name drugs from differed places of origin must be furnished; or, according to the relevant technical guidelines for the research and evaluation of biosimilars in China's drug regulatory authorities, a comparative research shall be carried out on the brand-name drugs of different origins to prove that they are comparable (similar/consistent), and a pre-trial supplementary application must be filed with NMPA Center for Drug Evaluation for review and approval, only after which the applicant may use the brand-name drug that has not been approved in China for the clinical trial.

III. The reference drugs selected by the applicant at each stage of R&D for biosimilarity comparative research must be from the same place of origin.

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