Kaixian CHEN, the member of the national committee of CPPCC, said at the national committee of the conference that if a clinical trial project would be undertaken in 20 hospitals, those hospitals must be firstly approved by their Ethics Committee and then make declarations to the human genetic resources management office of Ministry of Science and Technology of PRC respectively. This process need a huge effort and would greatly delay the test process. Over the past year, China’s new drug research and development institutions generally reacted strongly on this issue.

It is understood that the clinical trial project which was joined by foreign pharmaceutical enterprise and research institution must be approved by the human genetic resources management office. In CHEN’s opinion, those regulations make the clinical trial project to be approved as long as conform to one of the conditions that research institution (include partner)has foreign investment, principal is foreigner, the trial entrust international CRO company in design and quality management. It poses a large burden to the clinical trial project in practice.

So he suggested that those drug clinical trials which related to the use of human genetic resource without any approval must be examined and approved strictly by the human genetic resources management office. While, for those clinical trials which have been ratified by China Food and Drug Administration, they should be managed and approved in a simplified and efficient way, for the samples and information are saved in Chinese hospitals and actually controlled by Chinese research institution. Thus, the protection of genetic resources would gain a basic insurance. At the same time, CHEN suggested that the way of report for approval should be simplify and the speed of approval should be accelerated. All of that, the biomedical innovation should be promoted.

Time: 2017-03-08

Source: China Science Daily