The ISSCR submitted comments to China's National Medical Products Administration regarding China's draft regulations for the Management of Clinical Research and Transformation Applications for Somatic Cell Therapy.
China's newly proposed regulations will provide "incentives for hospitals to market unsafe and ineffective interventions directly to consumers," according to the comments. The ISSCR urges China to rescind the draft regulations and limit the use of stem cell-based intervention to well-regulated clinical trials and products approved by the National Medical Products Administration after the completion of clinical trials demonstrating safety and effectiveness.
Among other things, the ISSCR urges China to:
- publish pre-clinical studies to enable independent peer reivew of the science, and publication of all clincal results, to advance understanding and inform other clinical invesigations;
- maintain rigorous review pathways to ensure stem cell-based products conform to the highest standards of evidence-based medicine;
- Improve the informed consent process for new biomedical technologies.