The ISSCR welcomes the new policy guidance from Health Canada that clarifies the regulation of autologous cell products in Canada. Last year, the ISSCR urged Health Canada to harmonize Canada’s regulations with the international community to prevent the premature marketing and commercialization of cell therapies whose safety and effectiveness have not yet been established in clinical trials. The new policy guidance aligns Canada’s regulations with the U.S. Food and Drug Administration’s 2017 Regenerative Medicine Framework and the Australian Therapeutic Goods Administration’s 2018 Autologous human cell and tissue product regulations.

With the rapid growth of the stem cell field and advances in regenerative medicine, it is critically important that researchers earn and retain the public trust. To that end we must operate under agreed-upon guidelines that ensure ethical activities, transparency, and sound science.

In response to draft regulations in China on gene editing and other potentially risky biomedical technologies, the ISSCR has submitted comments to the the country's National Health Commission Medical and Medical Administration Bureau.

The ISSCR supports research using human-animal chimeras conducted under appropriate review and oversight (ISSCR Guidelines Recommendation 2.1.5) and applauds the new Japanese rules enabling research on chimeric embryos. Research involving human-animal chimeras has led to increased understanding of human development and biology, with implications that have the potential to significantly impact human health.

Scientists play a critical role in advocating for research that is advancing healthcare and biomedicine…