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China Introduces Guidelines for Imports of Reference Products of Biomedicines for Clinical Trials

Guidelines relating to the import of reference products of biomedicines for clinical trials of biosimilar products have been released by the National Medical Products Administration (NMPA)with key points as follows:

  • Applicants should, where possible, opt to import the original drugs already approved by China for general import or for use in clinical studies when conducting equivalence tests on their proposed biosimilar products.
  • In order to protect the safety of the test subjects in clinical trials, should the place of production of the original drug to be imported differ from that of the drug previously approved for import, the applicant must either demonstrate the consistency of the drug across its various production bases or conduct research to establish such consistency. In both instances, a supplemental application must then be submitted to the NMPA’s Center for Drug Evaluation. Any original drug sourced from an unapproved location may not be used as part of a clinical trial until the Center has duly accredited it.

Source: National Medical Products Administration

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