China has published a draft of proposed guidance on stem cell research and will accept comments on the document until April 10, setting the stage for policy changes in an innovative focus area which follow guidelines on biosimilars passed last year.
The draft would merge two existing regulations on stem cell research that separated approvals for companies running trials of stem cell therapies and those for certain patients.
The move would formalize clinical trial procedures in both cases.
|China President Xi Jinping|
China reorganized its oversight of food and drugs in March 2013 as part of a broad safety push under the government led by President Xi Jinping that officially elevated the State Food and Drug Administration (SFDA) to the ministry level and renamed it the China State Food & Drug Administration (CFDA). In addition to the new name, the reorganization combines a number of functions previously carried out by other offices and departments below the CFDA.
Since the restructuring, China has moved on clinical trial rules, including a review of multiregional clinical trials as well as international harmonization of standards, drug approvals, device clearance and good manufacturing practices. However, despite efforts to streamline the drug-approval process, the backlog jumped by a third last year.
- here's the CFDA website (Chinese)