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 standardise the rule of accepting the overseas clinical trial data of drugs.
This effective version generally follows the previous draft version. 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. The rule may be relaxed for drugs that are partially accepted when it relates to applications for drugs of critical and rare diseases or paediatric medication and provided that the market currently lacks an effective treatment.
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.