China Issues Guidelines for Drug Imports Used in Clinical Trials

China’s National Medical Products Administration issued guidelines for the imports of reference products of biomedicines for clinical trials, according to a July 5 report from the Hong Kong Trade Development Council. Among the key points in the guidelines, China is urging applicants to import “original drugs already approved by China for general import” when they conduct “equivalence tests on their proposed biosimilar products.” In addition, if the location where the imported drug was produced differs “from that of the drug previously approved for import,” the applicant is required to “demonstrate the consistency of the drug across its various production bases or conduct research to establish such consistency,” the report said. In either case, the applicant must submit a “supplemental application” to the NMPA’s Center for Drug Evaluation. Drugs that are sourced from an “unapproved location” will not be allowed as part of a clinical trial until the center “has duly accredited it,” the report said.