Center for Medical Device Evaluation held a Seminar on Technical Guidance for Accepting the Overseas Clinical Trial Data of Medical Devices on December 19 in Beijing. Gao Runlin, Academician of Fuwai Hospital and Deng Gang, deputy director of the Center, attended the meeting.
Gao Runlin pointed out that under the premise of clinical trial data meeting the requirements of China’s technical review, the guiding principle has opened up a path for accepting data from overseas clinical trials, which can effectively avoid repetitive clinical trials and accelerate the listing of innovative medical devices in China, better meet the public clinical needs of medical devices, and is conducive to the early realization of the strategic goal of healthy China 2030. Deng Gang (Deputy Director) pointed out that in order to implement the directives of the Advice on Deepening Reform of Examination and Approval System and Encouraging Innovation in Drugs and Medical Devices (TZ [2017] No. 42, hereinafter referred to as The Advice), the Center for Medical Device Evaluation established 34 cross-sectoral project teams to realize the complementarity among sectors and fully guarantee the smooth progress of the reform. The Advice in the reform measures of “reforming clinical trial management”, clearly set out the requirements of “accepting data from overseas clinical trials”. Under this background, the project team of clinical trial Management has drafted this guiding principle.
Participants discussed the key issues in the feedback, including the requirements for the quality management of overseas clinical trials, the requirements for the data from overseas clinical trials, the impact the difference between the test population at home and abroad and the test conditions on accepting the data from overseas clinical trials. The project team will revise and perfect the guiding principles according to the opinions of the meeting, and form a manuscript for review.
