China to adjust registration management for drugs and medical devices
To promote the adjustment of industrial structure and technological innovation in the drug and medical device products sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017. The guideline lays out several primary objectives. These include overhauling the management of clinical trials, accelerating the drug and medical device approval process, promoting drug innovation and the development of generic drugs, enhancing the administration of drug and medical devices throughout the product life cycles, and improving technical review infrastructure for greater transparency and oversight. Notably, the guideline stipulates that qualified overseas clinical trial data can now be used in the drug andmedical device products registration and approval process. In the face of a grave threat to public health, drug and medical device registratio...
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