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China issues the rule of accepting overseas clinical trial data of drugs

Posted on October 26, 2018 at 12:45 AM
The China National Drug Administration issued the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs (Principles) on 10 July 2018, which standardize the rule of accepting the overseas clinical trial data of drugs. According to the Principles, overseas clinical trial data provided by applicants for drug registration in China shall be complete, correct, true and traceable. The process of obtaining the overseas clinical trial data shall comply with both the Good Clinical Practice of China and the ICH. The applicant shall submit comprehensive data concerning biopharmaceutics, clinical pharmacology, effectiveness and safety. After a review, the CNDA may choose to fully accept, partially accept or refuse to accept the submitted overseas data. Multi-national pharmaceutical companies will significantly benefit from these Principles, from the reduced cost of conducting clinical trials in China and the significantly reduced registration timeline.

Categories: Compliance Trends

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