China could have guidelines governing stem cell and similar research and treatments by midsummer, the China FDA said in a meeting with local experts in the field.
The intent appears to be on a fast track, for the government could easily adopt the standards of the International Society for Stem Cell Research as its guidelines, one meeting attendee told the China Securities Journal.
He said the international standard essentially is the guideline and could be used as a blueprint for any modifications. The expert group presented the agency feasibility studies containing the details of the recommended guidelines.
The group of experts urged the agency to establish the guidelines as soon as possible so the medical industry and academia could push ahead with their research, which because of existing rules and regulations, remains in its early stages.
Chinese research on stem cells reaches back into the 1980s when fetal liver stem cells were implanted in 11 patients, 9 of whom are still living.
The newspaper listed Grandhope Biotech, Shanghai Fosun Pharmaceutical and VCAN Bio as Chinese companies involved in stem-cell treatments.
Agency officials said that with support from the industry and academia, developing the guidelines could be accelerated and drafted as early as midyear.
The expert group also suggested the government adopt the U.S. use of a "compassion rule," in which patients in critical need of a last-ditch treatment be allowed to undergo stem-cell therapy without having to wait for efficacy trials.
- for the article from Want China Times
- here's the China Securities Journal (in Chinese)