The General Office of the State Drug Administration ("SDA") has recently issued the Good Manufacturing Practice for Drugs Used in Clinical Trials (Draft for Comment) (the "Draft for Comment") to seek public opinions by August 15, 2018.
The Draft for Comment is organized into thirteen chapters, including "quality management", "personnel", "plants and equipment", "pharmaceutical ingredients, excipients and packaging materials", "documents" and "manufacturing management", and contains an appendix, the Active Pharmaceutical Ingredients Used in Clinical Trials, to specify relevant requirements. According to the Draft for Comment, an applicant shall be responsible for the quality of pharmaceuticals used in clinical trials; in the event that the applicant is not the manufacturer of pharmaceuticals used in clinical trials, it shall audit the manufacturer's quality management system and enter into a quality agreement with the manufacturer to specify the responsibilities of each party, so as to ensure the quality of pharmaceuticals to be used in clinical trials is superior enough to satisfy the expected uses. Furthermore, the Draft for Comment expressly states that drugs to be used in clinical trials should be manufactured as much as possible via dedicated or independent production facilities and equipment; where there is no choice but to manufacture such drugs via the production lines for launched drugs, it is required to have a relatively comprehensive knowledge of the toxicity, pharmacological activity and potential sensitization of those drugs used in clinical trials and conduct an all-round evaluation of risks arising to launched products that are manufactured via the same production line.