The China National Health and Planning Commission (CNHPC), China Food and Drug Administration (CFDA) and China Traditional Chinese Medicine Administration (CTCMA) jointly issued a regulation entitled Measures for Administration of Clinical Research Projects of Medical Institutions (the “Regulation”), which became effective on October 16, 2014.
In addition to the existing CFDA regulations on clinical studies, the Regulation establishes new rules for medical institutions conducting clinical research, including medical research on human drugs and medical devices, as well as other research conducted by doctors.
Every medical institution must establish a Clinical Research Management Commission (CRMC) to oversee, review and approve clinical research projects. Before it can be implemented, each clinical research project must first be approved by the ethic committee and then by the CRMC. After final approval by the CRMC, the research project must be filed with the local public health authority.
Notably, the CRMC may not approve a clinical research project or suspend an on-going project under the following circumstances:
- the research may be violating laws, regulations or ethical rules;
- the drug or medical device products involved in the research may have quality defects;
- there are safety risks associated with the research that cannot be sufficiently controlled;
- the person responsible for research has a “direct interest” in the research outcome;
- there may be commercial bribery or other conflict of interests involved in the research; or
- the research may infringe on intellectual property rights of others.
The Regulation will have a significant impact on clinical research activities in China. It covers some previously unregulated clinical research by medical institutions; it also adds an extra layer of approval at the hospital level to those drug and medical device studies sponsored by manufacturers, which are already subject to CFDA approval. It remains to be seen how the Regulation will operate in coordination with the existing CFDA clinical study rules; and it is also critical to see how each medical institution will implement the requirements of the Regulation, for example, when approving each study, how to identify any IP infringement issues and how to determine doctors’ direct interests in the research.