The State Drug Administration ("SDA") has recently issued the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs (the "Guiding Principles").
The Guiding Principles make clear the sphere of application, basic principles, completeness requirements, technical requirements on data submission, and to what extent data will be accepted, with respect to the acceptance of overseas clinical trial data. Further, the Guiding Principles require that applicants shall ensure the truthfulness, completeness, accuracy and traceability of overseas clinical trial data. The process of how such data is formed shall comply with relevant requirements stated in the Good Clinical Practice ("GCP") provided by the International Council for Harmonization (ICH). Also, applicants shall ensure overseas clinical trials are designed scientifically, the quality management system for clinical trials meet relevant requirements, and the statistical analysis of data is accurate and complete. Furthermore, the Guiding Principles specify different requirements on the submission of different categories of data, and, depending on the quality of clinical trial data, classify the acceptance of clinical trial data into three situations, i.e. fully accepted, partially accepted and rejected.