China Strengthens Clinical Trial Approval Rules for Cell and Gene Therapies

China issued a draft of new rules that regulate initial clinical trial approvals of high-risk cell and molecular therapies, establishing fines and criminal penalties for individuals and institutions that do not follow the policies. After last year's CRISPR scandal, gene editing and gene transfer figure prominently in the new rules. The new regulations create a two-tier system that distinguishes between high and low-risk technologies. Initially, clinical trial applications will be reviewed by provincial authorities. High risk technologies will be sent to the National Health Commission for a final review, all within the 60-day maximum already in place for China clinical trial reviews. More details....

Share this with colleagues: