China releases draft stem cell clinical trial regulation

03 July 2015

Alison Wong, Dr David Pountney

To date China has had one of the most unrestrictive embryonic stem cell research policies in the world.  According to the U.S. National Institutes of Health there were 164 stem cell clinical trials taking place in China during 2014, second only in number to the U.S. and Europe. In order to improve the regulatory pathway for stem cell trials, in March 2015 the China Food and Drug Administration (CFDA) released a draft guidance document, the Management Measures on Clinical Trial of Stem Cells, for public consultation and comment.

Before the new guidance was issued, two authorisation procedures concerning stem cell therapies existed in China. Historically, the CFDA has granted authorisation to companies running clinical trials using stem cells that were intended to become commercial stem cell therapies, and the National Health and Family Planning Commission (NHFPC) was responsible for the authorisation of individual stem cell procedures on a patient-by-patient basis under a high-risk medical technology classification. Under the new regulation, all stem cell research will be overseen and authorised by the CFDA with a new approval pathway being put in place.

The guidance states that only top-tier Class IIIa medical institutions, of which there are over 400, are qualified to conduct stem cell research. Good Clinical Practice (GCP) measures must be in place, including informed patient consent. Medical institutions are also required to have an ethics committee in place, although operational management of trials is the responsibility of an independent academic committee.

The new regulations also call for the safe retention and storage of all clinical records of stem cell donors and patients for a period of at least 30 years. Further provisions require the ongoing monitoring of patients who have received stem cell transplants in clinical trials to ensure the long-term safety and efficacy of the new therapies. A national advisory board with provincial health authorities has been established by the Ministry of Health to monitor compliance with the new regulation. It remains to be seen whether implementation of the new regulation will simplify and expedite the approval of stem cell trials and whether China will remain a prime destination for international companies to conduct such trials.

This article is part of the International Life Sciences Update for July 2015.



Alison Wong

China and Hong Kong

Call me on: +852 2248 6000