One year after China strengthened regulations on the use of human genetic materials in clinical trials, new reporting requirements would make the regulations even more stringent – and more challenging for multinational pharmaceutical and medical device companies conducting such trials in China.
Under the new Biosecurity Law, still in draft form, existing requirements would be bolstered to cover how genetic families of human genetic resources (HGR) are collected, how international research using Chinese HGR is conducted, and how HGR is preserved, shipped and mailed. Review of the draft legislation is proceeding quickly, given the potential applications of HGR for research into the development of a COVID-19 vaccine.